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pdfDATA USER'S MANUAL
for the
Colorectal Cancer Screening
Demonstration Program
Version 1.01
April 2006
Centers for Disease Control and Prevention
National Center for Chronic Disease Prevention
and Health Promotion
Introduction
This manual was written by the Centers for Disease Control and Prevention (CDC) to
centralize the information needed to produce data for the Colorectal Cancer Screening
Demonstration Program (CRCSDP). This manual refers to the CRCSDP awardees as
‘programs’. One goal of the manual is to provide the technical information necessary for
the programs to produce the Colorectal Cancer Clinical Data Elements (CCDEs).
Another goal is to highlight the technical assistance provided to the programs by the
CDC and the data contractor, Information Management Services, Inc. (IMS). A common
goal of the CDC and the programs is to produce data that are timely, complete, and of
high quality so that we can better serve the clients targeted by the program.
The intended audience for this manual is the program staff responsible for the collection
and aggregation of the CCDE data. It is divided into 7 chapters as follows:
Chapter 1
Data Submission
This chapter contains the dates that the Colorectal Cancer Clinical Data
Elements (CCDEs) are to be submitted to IMS, along with the technical
requirements for submission.
Chapter 2
Colorectal Cancer Clinical Data Elements (CCDEs)
This chapter includes a general introduction to the CCDEs, detailed field
descriptions, a listing of the aggregate data required for non-enrolled
clients and information on reporting complications.
Chapter 3
Data Quality Assessment
This chapter describes a variety of ways to assess the quality of program
data including computer listings and the CCDE Service Quality Indicators
used by the CDC for evaluation.
Chapter 4
Registry Linkage
This chapter describes methods to be used to assist in linking with the
state cancer registry and variable definition tables that outline each of the
collaborative stage variables collected in the CCDEs.
Chapter 5
Communications
This chapter provides a central location to store the information provided
to the program from the CDC.
Chapter 6
Meeting Minutes
This chapter provides a central location to store notes and minutes from
conference calls and meetings.
Chapter 7
References
This chapter contains optional reading material related to colorectal
cancer screening. Also included are definitions for common program
abbreviations and concepts.
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Introduction
Introduction
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Table of Contents
Chapter 1
Data Submission
CCDE Data Submission ................................................................................. 1
What......................................................................................................... 1
When........................................................................................................ 1
How .......................................................................................................... 2
Updates and Corrections ......................................................................... 2
Edit Program ............................................................................................ 2
Submission Narrative ............................................................................... 2
IMS and the CCDEs ................................................................................. 3
Submitting Annual Aggregate Data on Medically Ineligible Clients ................. 4
What ....................................................................................................... 4
When ....................................................................................................... 4
How ....................................................................................................... 4
Software Selection........................................................................................... 4
Appendix A – CCDE Submission Narrative Guidelines ............................... A-1
Appendix B – Annual Aggregate Data on Medically Ineligible Clients......... B-1
Chapter 2
CCDEs
Introduction to the CCDE Chapter................................................................... 5
Understanding CCDE Data ............................................................................. 7
Colorectal Cancer Clinical Data Elements ............................................... 7
CCDE Cycle Definition ............................................................................. 7
Structure of the CCDEs............................................................................ 7
Race and Hispanic Origin ........................................................................ 9
Unique Client Identifier............................................................................. 9
Data Conventions................................................................................... 10
Dates .............................................................................................. 10
Alphanumeric Fields ....................................................................... 10
Numeric Fields ................................................................................ 10
Blank Filled Fields........................................................................... 10
CCDE Field Descriptions
Section 1 Program and Enrollment Data.............................................. 11
Section 2 Client and Record Identification ........................................... 18
Section 3 Demographic Information..................................................... 21
Section 4 Screening History................................................................. 32
Section 5 Colorectal Cancer Risk Factors ........................................... 48
Section 6 Screening and Diagnostic Tests Provided ........................... 56
Section 7 Diagnosis Information for All Polyps/Lesions ..................... 115
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Table of Contents
i
Table of Contents (continued)
CCDE Field Descriptions (cont’d)
Section 8 Diagnosis Information for Surgeries Performed to
Complete Diagnosis ......................................................................... 130
Section 9 Final Diagnosis................................................................... 133
Section 10 Diagnosis Information for Cancer/High Grade
Dysplasia.......................................................................................... 140
Section 11 Treatment Information........................................................ 150
Section 12 Record Information............................................................. 155
Appendix C - CCDE Data Definition Table .................................................. C-1
Appendix D – CDC Race and Ethnicity Code Set ....................................... D-1
Appendix E – Adverse Events Reporting Form ........................................... E-1
Appendix F – CCDE Revision History ..........................................................F-1
Chapter 3
Data Quality Assessment................................................................................. 157
Chapter 4
Registry Linkage ............................................................................................... 159
CCDE Item 10.4:
CCDE Item 10.5:
CCDE Item 10.6
CCDE Item 10.7
CCDE Item 10.8
CCDE Item 10.9
Registry primary site ...................................................... 161
Registry CS-derived SS2000 ......................................... 165
Registry CS-derived AJCC stage group......................... 167
Registry CS extension.................................................... 169
Registry CS lymph nodes............................................... 175
Registry CS mets at diagnosis ....................................... 177
Chapter 5
Communications............................................................................................... 179
Chapter 6
Meeting Minutes................................................................................................ 181
Chapter 7
References......................................................................................................... 183
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CHAPTER 1
Data Submission
CCDE Data Submission
What: CCDE data are submitted quarterly to IMS. Each CCDE submission will include
cumulative data from the beginning of screening through the submission cut-off date, which is
three months prior to the due date. For example, if the data are due to IMS on 9/1/2006, the
data should cover procedures performed from the onset of the screening program through
5/31/2006. Note that the date used for the cut-off should be the date of first test provided and
not, for example, the date of eligibility. It is important to use the cut-off date and not send all
data through the submission date. The three month lag time between the procedure date and
the reporting of the CCDE data will allow time to collect and clean the data. Submitted records
may have incomplete diagnostic or treatment data that will be updated on a subsequent
submission. Each submission dataset will replace the previous submission in its entirety.
The CCDE data file should only contain records on clients who were enrolled in the colorectal
screening program and who received services using CDC funds. This includes clients who are
determined eligible and who are given a take-home FOBT/FIT kit, regardless of whether they
complete the test.
Any data regarding clients seen, but not screened through this program due to medical
ineligibility should be reported in the aggregate data file. Details regarding the aggregate data
file, a sample form, and submission information can be found in subchapter “Non-clinical
Aggregate Data Submissions”.
When: CCDE data are submitted to IMS according to the schedule below.
Please notify your IMS Clinical Data Technical Consultant if your data are going to be late. Data
not received by the submission due date may not be included in the analyses performed for that
specific submission.
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Submission Due
Submission Cut-off Date
9/1/2006
5/31/2006
12/1/2006
8/31/2006
3/1/2007
11/30/2006
6/1/2007
2/28/2007
9/1/2007
5/31/2007
12/01/2007
8/31/2007
3/1/2008
11/30/2007
6/1/2008
2/29/2008
9/1/2008
5/31/2008
12/1/2008
8/31/2008
Chapter 1 – Data Submission
1
How: When a CCDE submission is due, the CCDE data must be extracted from your dataset
and put into the standardized CCDE format. The CCDE file consists of fixed length records in
an ASCII format. In Version 1.01 of the CCDE Data Definition Table, each record will have 548
characters of screening, diagnosis, and treatment information and a 2 character end-of-record
delimiter for a total of 550 characters per record. The end-of-record delimiter will be a "carriage
return-line feed". A detailed description of the CCDE fields in each record is included in Chapter
2.
The CCDE file must be submitted electronically using the secure www.crcsdp.org Web site.
The size of a file can be reduced by using a data compression routine, such as WinZip, PKZip,
etc. IMS and the CDC request the use of compression software to compress your CCDE data
prior to submission.
It is necessary for each program to name their CCDE file using the following naming convention:
XXX -> Program code (001=Maryland)
MM -> Month of submission due date, with leading zeroes (09=September)
YY -> Year of submission due date (06=2006)
VVV -> CCDE version number (100=CCDE version 1.00)
Example: 0010906100.txt = (XXXMMYYVVV.txt)
All files should be received by IMS by close of business on the due date. Please notify Bill
Helsel ([email protected]) at IMS, the first time that data are submitted electronically so that
we can monitor the data transmission.
Also to be included with each submission is a Submission Narrative. A hard copy of the CCDE
Submission Narrative Guidelines can also be located at the end of this chapter – Appendix A.
An electronic copy may be found on the www.crcsdp.org Web site.
The following extensions should be used for the various file names:
CCDE data file -> *.TXT
Compressed CCDE file -> *.ZIP
Submission Narrative -> *.NAR
Updates and Corrections: For each data submission, programs are required to submit a
cumulative data set through the cut-off date. Therefore, if any changes or updates to a
particular record occur between submissions, these changes will be incorporated within the next
CCDE data file.
Edit Program: IMS will develop an edit program that should be run using the CCDE data file
prior to each CCDE submission. The edit program will perform basic validation routines and
report on invalid values, missing fields, and cross-field edits. The edit program and further
instructions on its use will be provided via the www.crcsdp.org Web site.
Submission Narrative: CCDE data are regularly reviewed by the CDC, IMS, and program
staff. Often questions arise from these reviews, and sometimes these questions lead to
modifications to the CCDE data and/or its processing. The Submission Narrative Guidelines
provide a structured way for programs to report responses to these questions or data
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modifications. The Guidelines have two main sections. Section I is where responses to Action
Items (written questions from the CDC and IMS based on a data conference call) are provided.
Section II is comprised of five questions that require programs to do a prospective review of
their CCDE data prior to submitting it to IMS. It is expected that programs should have the
capability to review and manage their data, and should not rely solely on the CCDE submission
feedback provided by CDC and IMS. A response to each of the five questions is required, even
if that response is “N/A - Not applicable”.
IMS and the CCDEs: Once the CCDE data are received at IMS they are reviewed and
validated. Using SAS, listings and print sample records for each program are produced to
check data quality. A SAS analysis file is created that attempts to clean up invalid data and
eliminate duplicate screening results. A series of reports are then generated to assess the
completeness and accuracy of these data, as well as to document the percentage of abnormal
screening results that have complete diagnostic and treatment data. These data are assessed
to determine progress in meeting program goals. Samples of the reports will be provided in
Chapter 3 “Data Quality Assessment” of this manual once they have been finalized.
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Chapter 1 – Data Submission
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Submitting Annual Aggregate Data on Medically Ineligible Clients
What: Each program is asked to submit an aggregate data report which contains counts of
clients who are assessed as medically ineligible and referred outside of the CRCSDP for
appropriate clinical evaluation and management. These data will be used by the CDC and
Research Triangle Institute (RTI) for program evaluation. A copy of the Annual Aggregate Data
on Medically Ineligible Clients report form can be found on the www.crcsdp.org Web site and in
the CRCSDP Policy Manual, Appendix 4.
When: All programs will submit the aggregate data reporting form according to the submission
schedule listed below:
Information on clients deemed ineligible from
March 1, 2006 – August 31, 2006
September 1, 2006 – August 31, 2007
September 1, 2006 – August 31, 2008
Data due to CDC
December 1, 2006
December 1, 2007
December 1, 2008
How: The form should be submitted to the CDC Program Consultant.
Software Selection
Each program needs to decide which computer software to use for data management. The
decision must balance the unique needs of the program, the cost of developing an in-house
system, as well as the suitability of available software.
If at any time a program chooses to convert their existing data system to a different software
package, it is strongly recommended that a test data submission be sent to IMS for review. The
test submission should be done well in advance of a CCDE submission deadline. The IMS
Clinical Data Technical Consultant should be notified prior to sending the test data.
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Appendix A
CCDE Submission
Narrative Guidelines
CCDE Submission Narrative Guidelines
March 31, 2006
The submission narrative provides a structured way for programs to respond to
questions or issues identified during the CCDE data review.
The submission narrative is comprised of two sections:
I.
The first section should include written responses to any action items that
were identified in the previous data submission. Following the review and
discussion of the program’s CCDE data file by the CDC Program Consultant,
CDC Scientific Consultant and IMS Clinical Data Technical Consultant and
program staff, an Action Plan will be developed. The CDC Program
Consultant will provide this information to the appropriate staff at the program.
Each action item should be addressed by the program in this first section.
II.
The second section should address the following questions. If the question is
not applicable to your program at this time, please indicate “N/A”:
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1.
Summarize reasons for any significant data issues identified by the
program but not resolved prior to submitting the CCDE file to the CDC.
2.
Identify any modifications made to the software which generates the
CCDE file that would cause significant changes in the distribution of
the values for individual data items.
3.
Identify any batch recoding of records in the CCDE file that would
cause significant changes in the distribution of the values for individual
data items.
4.
Identify any data management staffing, system, or procedural changes
that would affect the data management capacity. Examples of these
include staff turnover, revision of data collection forms, revision of data
entry screens, a change in the data collection model (i.e. centralized to
decentralized), etc.
5.
Identify any plans to significantly upgrade existing data management
software, or to develop and migrate the client database to a new data
management system.
Chapter 1 – Appendix A
A-1
A-2
Chapter 1 – Appendix A
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Appendix B
Annual Aggregate Data on Medically
Ineligible Clients
This appendix is a placeholder for the Annual Aggregate Data on
Medically Ineligible Clients Form which can be located in the CRCSDP
Policy Manual, Appendix 4.
CHAPTER 2
Colorectal Cancer Clinical Data
Elements (CCDEs)
Introduction to the CCDE Chapter
The purpose of this chapter is to provide the programs with the information necessary to
collect the CCDE data.
•
Understanding CCDE data
This chapter provides information regarding the structure of the CCDEs, the
definition of a screening cycle, information about collecting and reporting Race
and Hispanic Origin data, creating a unique client identification number, and
details regarding data conventions used in reporting CCDE items.
•
CCDE Field Descriptions
A detailed description of each CCDE data item. This is the format that must be
followed for the CCDE data submissions to the CDC.
•
Appendix C - CCDE Data Definitions
The list of CCDE variables with brief field descriptions and file layout
specifications. This is appropriate for quick reference.
•
Appendix D – CDC Race and Ethnicity Code Set
A table which lists each of the Standard Race Categories, along with an
expanded subset of concepts.
•
Appendix E – Adverse Events Reporting Form
These guidelines should be used when reporting any adverse events
experienced by clients who receive a sigmoidoscopy, colonoscopy, or double
contrast barium enema for screening or diagnostic purposes through the
CRCSDP.
•
Appendix F – CCDE Revision History
These tables will be used to identify changes made to specific variables over the
history of the program.
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Chapter 2 - CCDEs
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Chapter 2 - CCDEs
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Understanding CCDE Data
Colorectal Cancer Clinical Data Elements
The Colorectal Cancer Clinical Data Elements (CCDEs) are a set of standardized data elements
developed to ensure that consistent and complete information on client demographic
characteristics, screening history, risk factors, screening and diagnostic tests, diagnosis and
treatment information are collected on clients screened or diagnosed with program funds.
These are the data items that are necessary for the programs and the CDC to manage and
evaluate the clinical component of this demonstration program. Programs may collect additional
data for local use (not to be reported to CDC) if they choose. The CCDEs are collected for
each screening event for each client, then computerized, converted into a standardized format,
and transmitted to IMS.
CCDE Cycle Definition
A CCDE cycle is reported in one CCDE record. A CCDE cycle begins with either an initial
colorectal cancer screening test, which can include the distribution of an FOBT/FIT kit, or a
surveillance colonoscopy, performed on a client who enters the program with a prior history of
colorectal polyps or cancer. Once the cycle begins, it continues through any additional tests or
procedures required for diagnostic evaluation following an abnormal or incomplete test, and
ends when a final diagnosis is determined, and treatment is initiated if indicated
Structure of the CCDEs
The CCDEs consist of twelve main sections. Each section contains specific variables to provide
detailed information about the client’s screening cycle.
Section 1: Program and Enrollment Data
This section contains detailed information about eligibility and how the client heard about the
program. It must be completed for each client and each CCDE record for that client.
Section 2: Client and Record Identification
This section contains client identification (to identify one client among many) and record
identification (to identify one screening cycle among many for a client). It must be completed for
each client and each CCDE record for that client.
Section 3: Demographic Information
This section contains specific demographic information about the client. The information
collected in this section must be self-reported by the client. This information must be completed
for each client and each CCDE record for that client.
Section 4: Screening History
This section contains information regarding previous screening and diagnostic tests. The
information collected in this section can be self-reported by the client, or can come from
information documented in the client’s medical record. Medical record information is preferred, if
available. This information must be completed for each client and each CCDE record for that
client.
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Chapter 2 – Understanding CCDE Data
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Section 5: Colorectal Cancer Risk Factors
This section contains risk factor information, such as previously diagnosed polyps or colorectal
cancer. It must be completed for each client and each CCDE record for that client.
Section 6: Screening and Diagnostic Tests Provided
This section contains information regarding the types of screening or diagnostic tests performed
within each screening cycle. This information must be completed for each client and each
CCDE record for that client.
Section 7: Diagnosis Information for All Polyps/Lesions
This section contains data regarding size, location and histology of any polyps or lesions
discovered during the screening cycle. It also contains information regarding the next
recommended procedure for the client within the current screening cycle. This section must be
completed for each client and each CCDE record for that client.
Section 8: Diagnosis Information for Surgeries Performed to Complete Diagnosis
This section contains data regarding the date of surgery and histology from the surgical
resection. This section should be completed anytime the client has surgery recommended to
complete the diagnosis for the screening cycle.
Section 9: Final Diagnosis
This section contains data regarding a final diagnosis for the screening cycle and the
recommended tests for the next screening cycle. This section should be completed for each
client and each CCDE record for that client.
Section 10: Diagnosis Information for Cancer/High Grade Dysplasia
This section collects staging information at time of diagnosis, and staging information collected
after linking with the state cancer registry. Guidance for this section will be provided by summer
2006.
Section 11: Treatment Information
This section collects treatment information for all clients with either a final diagnosis of “Polyp
with high grade dysplasia” or “Cancer”.
Section 12: Record Information
This section includes the CCDE version for data collected and an end of record mark.
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Race and Hispanic Origin
Federal Programs are required to use standards defined by the U.S. Office of Management and
Budget (OMB) for the classification of race and ethnicity data. Additional information is
available on the OMB Web site at http://www.whitehouse.gov/omb/inforeg/statpolicy.html#dr.
The race codes collected in the CCDEs mirror those required by the OMB. However, programs
may expand these categories during data collection to include racial subgroups that are
represented in the local population if they choose. For example, a program may be established
in an ethnic neighborhood where the clients may not feel that the CCDE category of ‘White’ is
appropriate. In this instance, expanding the category to include ‘Egyptian' or ‘Israeli’ may
promote a more complete collection of race information. In these instances, the data system
would then collapse these categories into ‘White’ prior to the CCDE submission to the CDC.
The same would hold true for collection of Hispanic origin. If a program finds that Hispanic
origin is being completed, with the Race fields being left blank, it may be more advantageous to
expand the Race categories to include ‘White – Hispanic’, ‘White – Non-Hispanic’, etc. These
categories could then be expanded to report Hispanic Origin and Race prior to the CCDE
submission to the CDC.
An expanded list of the CDC Race and Ethnicity Code Set is included in Appendix D to assist
programs in collapsing more specific race concepts into the standard race code set.
Unique Client Identifier
The client identification number used in the CCDEs must be unique and consistent throughout
the entire screening system. It is important, for program purposes, to be able to track clients
over time. A client identification number which is unique only to a clinic is not acceptable
because it cannot track a client between clinics. Programs may not have the capability to
assign the same unique identifier to a client who changes clinics. In these programs, matching
is routinely done to identify the relatively small number of clients who change clinics. Matching
can be done using date of birth, name (first, last, and maiden), and Social Security number.
Using a combination of any or all of these items assures a greater number of matches.
Completely numeric identifiers tend to work better, however the CCDEs allow the use of alphanumeric identifiers, if necessary. A social security number has the necessary attributes for a
good client identifier; however it is not always available. Additionally, confidentiality is of the
utmost importance. We, at the federal level, do not want an identification number that could be
used to link the CCDEs to other databases. Thus, if the Social Security number is used, you
must encode it prior to submission to the CDC. See the field description on Client ID for
encoding procedures.
It is important to realistically assess the various possibilities for the client identifier in your
program. This is how information is linked, and the importance of a unique and consistent
personal identifier cannot be over-emphasized.
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Chapter 2 – Understanding CCDE Data
9
Data Conventions
These are the general data conventions that apply to the CCDE data. However, the specific
information on each field should be followed for a CCDE submission.
Dates: All dates are entered in the form MMDDYYYY or MMYYYY. For example, January 6,
1942 would be entered as 01061942 for MMDDYYYY, or 011942 for MMYYYY. If any part of
the date is unknown, blank fill just that part. For example, if the month and year are known, but
the day is not, blank fill just the day (e.g., 01 1942). Date fields may not be missing the year
value.
Alphanumeric Fields: Alphanumeric or character data must be left-justified. In a left-justified
field, the field value is placed so that the first character of the value is in the first position of the
field. For example, the "Knowledge of program - other" field is left-justified in the CCDE file.
The starting and ending positions are columns 18 and 42, respectively. If the Other Specify is
Church Bulletin, then "Church Bulletin" would be placed in columns 18 through 32 with the "C"
being placed at column 18 and the "n" being placed in column 32. Columns 33 through 42
would be filled with blanks.
Numeric Fields: Numeric fields are right-justified. In a right-justified field, the field value is
placed so that the last character of the value is in the last position of the field. For example, the
"Largest Number of Polyps" field (Item 5.2.2) is a 2-digit numeric code and it is right justified.
The starting and ending positions are columns 162 and 163, respectively. If the largest number
of polyps is 8, then "8" would be placed in column 163. Column 162 would be a blank.
Numeric fields may also be reported using the leading zero. So in the example given above, if
the largest number of polyps is 8, the “0” would be placed in column 162 and “8” would be
placed in column 163. The SAS programs used to analyze the CCDE data will recognize both
conditions. Programs are asked to be consistent in how numeric values are placed.
Blank Filled Fields: A blank filled field is filled with blank characters. If the field has a length of
six and, if it were appropriate to blank fill the field, it would contain six blank characters. It is
only appropriate to blank fill a field when it is indicated in the field description. A blank should
not be used as a substitute for an "unknown" response, if a valid "unknown" code exists.
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CCDE Field Descriptions
Section 1 - Program and Enrollment Data
ITEM NO / NAME: 1.1: Program
PURPOSE:
To indicate the unique identifier for the grantee program.
LENGTH:
3
TYPE:
Numeric – right justify
SKIP PATTERN:
This field should always be completed.
CONTENTS:
001 = Baltimore, MD
002 = St. Louis, MO
003 = State of NE
004 = Stony Brook, NY
005 = Seattle and King County, WA
EXPLANATION:
This is the three-digit code assigned by the CDC to be used by your
program for identification in lieu of state and territory FIPS codes.
EXAMPLE:
For Baltimore, MD: 001
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
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Chapter 2 – CCDE Field Descriptions
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Section 1 - Program and Enrollment Data
ITEM NO / NAME: 1.2: Date of eligibility
PURPOSE:
To indicate the date that a client was determined to be eligible to be
screened in the program.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
This field should always be completed.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a value
from 01 to 12, DD is a value from 01 to 31, and YYYY is the year of
eligibility. If just the year is known, blank fill the month and day. If
just the year and month are known, blank fill the day (e.g. 04
2006). At the minimum, the year must be reported.
EXPLANATION:
This is the date that the client was determined to be eligible to be
screened in the program. This could be the date of the initial
interview, the date that an enrollment form was completed, or the
test referral date.
EXAMPLE:
For a client determined eligible for the program on March 12, 2006:
03122006
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
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Chapter 2 – CCDE Field Descriptions
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Section 1 - Program and Enrollment Data
ITEM NO / NAME: 1.3.1: Knowledge of program (1)
PURPOSE:
To indicate how a client learned about the program.
LENGTH:
2
TYPE:
Numeric – right justify
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Doctor
2 = Other health care provider
3 = NBCCEDP
4 = Family member
5 = Friend
6 = Radio
7 = Television
8 = Magazine article
9 = Newspaper
10 = Mailing/flyer
11 = Community event
12 = Other
EXPLANATION:
The source for information about the program should be selfreported by the client. If the client indicates a source other than
those listed in 1 – 11, then report a response of 12 (Other) and
complete the free text field in Item 1.3.4 “Knowledge of program
other text field”. If more than one source, report using 1.3.2 and
1.3.3.
If programs choose to offer additional response options for this
question, plans should be made to collapse those additional
responses to 12 (Other) and complete the free text field in Item
1.3.4 “Knowledge of program other text field” when these data are
exported to the CCDE data file for reporting to CDC.
EXAMPLE:
If a client learns of the program from a radio advertisement: 6
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
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Chapter 2 – CCDE Field Descriptions
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Section 1 - Program and Enrollment Data
ITEM NO / NAME: 1.3.2: Knowledge of program (2)
PURPOSE:
To indicate how a client learned about the program.
LENGTH:
2
TYPE:
Numeric – right justify
SKIP PATTERN:
This field should be completed when more than one source is
indicated for knowledge of the program; otherwise leave blank.
CONTENTS:
1 = Doctor
2 = Other health care provider
3 = NBCCEDP
4 = Family member
5 = Friend
6 = Radio
7 = Television
8 = Magazine article
9 = Newspaper
10 = Mailing/flyer
11 = Community event
12 = Other
EXPLANATION:
The source for information about the program should be selfreported by the client. Use this field if the client indicates more than
one source for his/her knowledge of the program. No primary
source for knowledge of the program is collected. The first source
indicated by the client has no significance over any subsequent
source, and may simply be the first source mentioned by the client.
If the client indicates a source other than those listed 1 – 11, report
a response of 12 (Other) and complete the free text field in Item
1.3.4 “Knowledge of program other text field”. If more than two
sources, report in 1.3.3.
If programs choose to offer additional response options for this
question, plans should be made to collapse those additional
responses to 12 (Other) and complete the free text field in Item
1.3.4 “Knowledge of program other text field” when these data are
exported to the CCDE data file for reporting to CDC.
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Section 1 - Program and Enrollment Data
EXAMPLE:
If a client learns of the program from a community event: 11
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Section 1 - Program and Enrollment Data
ITEM NO / NAME: 1.3.3: Knowledge of program (3)
PURPOSE:
To indicate how a client learned about the program.
LENGTH:
2
TYPE:
Numeric – right justify
SKIP PATTERN:
This field should be completed when more than two sources are
indicated for knowledge of the program; otherwise leave blank.
CONTENTS:
1 = Doctor
2 = Other health care provider
3 = NBCCEDP
4 = Family member
5 = Friend
6 = Radio
7 = Television
8 = Magazine article
9 = Newspaper
10 = Mailing/flyer
11 = Community event
12 = Other
EXPLANATION:
The source for information about the program should be self-reported by
the client. Use this field if the client indicates more than two sources for
his/her knowledge of the program. No primary source for knowledge of
the program is collected. The second source indicated by the client has
no significance over any subsequent source, and may simply be the
second source mentioned by the client. If the client indicates a source
other than those listed 1 – 11, report a response of 12 (Other) and
complete the free text field in Item 1.3.4 “Knowledge of program other text
field”.
If programs choose to offer additional response options for this question,
plans should be made to collapse those additional responses to 12
(Other) and complete the free text field in Item 1.3.4 “Knowledge of
program other text field” when these data are exported to the CCDE data
file for reporting to CDC.
EXAMPLE:
If a client learns of the program from a radio advertisement: 6
REVISION HISTORY:
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Section 1 - Program and Enrollment Data
ITEM NO / NAME: 1.3.4: Knowledge of program other text field
PURPOSE:
To indicate an other source used to learn about the program.
LENGTH:
25
TYPE:
Alphanumeric – left justify
SKIP PATTERN:
If Item 1.3.1, 1.3.2, or 1.3.3 “Knowledge of program 1-3” is 12, then
this field must be completed; otherwise it should be blank.
CONTENTS:
This is a free form text field.
EXPLANATION:
The purpose of this field is to report client-identified sources for
knowledge of the program that are not among the response options
(1-11) that are provided in the three knowledge of program fields.
If programs choose to offer response options in addition to those
response options (1-11) that are provided in Items 1.3.1, 1.3.2, or
1.3.3 “Knowledge of program 1-3”, then plans should be made to
collapse those additional responses to 12 (Other) and complete the
free text field in Item 1.3.4 “Knowledge of program other text field”
when these data are exported to the CCDE data file for reporting to
CDC.
Please try to use this field appropriately. Reclaiming inappropriate
responses is time-consuming and could potentially result in the loss
of valuable data.
EXAMPLE:
If a client learns of the program via a Web site: Web site
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Section 2 - Client and Record Identification
ITEM NO / NAME: 2.1: Client identifier
PURPOSE:
To indicate a system-generated identification number for each
client that will be consistent for the client throughout the database.
LENGTH:
15
TYPE:
Alphanumeric (no special symbols) – left justify, case sensitive.
SKIP PATTERN:
This field should always be completed.
CONTENTS:
A fifteen-digit alphanumeric code. The client identifier must be
unique and constant for each client in your database in order to
track each client over time. A client identifier that is unique only to
a specific clinic or location is not acceptable because it cannot track
the client between locations. Completely numeric client identifiers
tend to work better; however, the CCDEs allow the use of
alphanumeric client identifiers if you find it necessary. If alphabetic
characters are included in the Client identifier field, they must be
entered consistently in uppercase or lowercase for all records for
each client.
Confidentiality is of the utmost importance. CDC does not want a
client identifier that could be used to link CCDE records to other
databases. Certain identification numbers such as Social Security
numbers lack this privacy. If Social Security numbers are used, or
any other number which has linking capabilities, then the client
identifier must be encoded. CDC does not want to know the
encoding scheme used by your program. However, your program
should derive an encoding scheme which you can decode back to
the original client identifier in the event that a problem is found.
The use of partial names and/or dates is also not recommended.
We provide the following suggestions and an example encoding
procedure which we hope will be helpful. Digit rotation and ninescomplement are two methods which, when combined, can be used
as an effective encoding scheme. Digit rotation is simply rotating a
set of digits either left or right. The nines-complement of a number
is nine minus the number, i.e. the complement of 2 is 7, the
complement of 5 is 4 and the complement of 0 is 9. An example of
an encoding procedure for the Social Security number, 123-456789 is as follows:
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Section 2 - Client and Record Identification
Procedure
Before/After
Nines-complement of digits 2,4,8,9
123-45-6789 / 173-55-6710
Rotate left - digits 1,3,5,6
173-55-6710 / 375-56-1710
Rotate right - digits 2,3,8,9
375-56-1710 / 307-66-1751
EXAMPLE:
Client identifier is 001000002357901: 001000002357901
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Section 2 - Client and Record Identification
ITEM NO / NAME: 2.2: Record identifier
PURPOSE:
To identify one record among many for a client.
LENGTH:
6
TYPE:
Numeric – right justify
SKIP PATTERN:
This field should always be completed.
CONTENTS:
A six-digit numeric code. This field will be used to identify one
unique record among many for a client. For example, the record
identifier can be a visit date or a sequential record number.
EXPLANATION:
A screening cycle begins with either an initial colorectal cancer
screening or surveillance test, or distribution of an FOBT/FIT kit,
continues through any additional tests or procedures required for
diagnostic evaluation following an abnormal or incomplete test, and
ends when a final diagnosis is reached and treatment is initiated,
when required.
Each CCDE record identifies a unique screening cycle for a client.
A client can have multiple screening cycles reported in the CCDE
data files. The record identifier helps to differentiate one screening
cycle among many for a client. The record identifier could be the
date of cycle initiation (e.g. FOBT date), or it could simply be a
sequential numbering (e.g. 1 = first cycle, 2 = second cycle, etc).
Programs are asked to be consistent in the method used for
creating a record identifier.
EXAMPLE:
Using a date of 4/1/2006: 040106
Using a cycle number of 1: 000001 or
1
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Section 3 - Demographic
ITEM NO / NAME: 3.1: Date of birth
PURPOSE:
To specify the date of birth self-reported by a client.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
This field should always be completed.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a
number from 1 to 12, DD is a number from 1 to 31, and YYYY is the
year of birth, including the century. If just the year is known, then
blank fill the month and day. If just the year and month are known,
then blank fill the day (e.g. 01 1955). At a minimum, the year of
birth must be reported.
EXPLANATION:
Date of birth must be self-reported by the client. This field is used
to compute age values and is vital to various analyses. It is,
therefore, important to provide as complete a date as possible.
EXAMPLE:
For a client born on May 1, 1953: 05011953
REVISION HISTORY:
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Section 3 - Demographic Information
ITEM NO / NAME: 3.2: Gender
PURPOSE:
To specify the gender self-reported reported by a client.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Male
2 = Female
9 = Other/unknown
EXPLANATION:
Gender must be self-reported by the client. A response of 9
(Other/unknown) in the context of this question could mean that the
client was not asked, the client’s answer was not recorded, the
client self-identified with a gender other than male or female, or the
client refused to answer the question.
EXAMPLE:
Client is female: 2
REVISION HISTORY:
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Section 3 - Demographic Information
ITEM NO / NAME: 3.3 Hispanic or Latino origin
PURPOSE:
To indicate the self-reported Hispanic or Latino origin of a client.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown/missing
EXPLANATION:
The method of identifying Hispanic or Latino origin must be selfidentification by the client. Consider placing this field prior to race
on the data form for better completion of the race/ethnicity data.
Hispanic Origin or Latino should be collected as a separate data
field from Race. If Hispanic or Latino origin is not collected
separately from race on your forms and a client reports race as
Hispanic, then Item 3.3 “Hispanic or Latino origin” should be
reported as 1 (Yes) and race should be reported as 9 (unknown). If
Hispanic or Latino origin is not collected separately and a client
reports race as something other than “Hispanic” or “Latino”, then
Item 3.3 “Hispanic or Latino origin” should be reported as 9
(Unknown/missing). If Hispanic or Latino origin is not asked of the
client, the answer is not recorded, the client doesn’t know or the
client refuses to answer, then report 9 (Unknown/missing).
EXAMPLE:
For a self-reported Hispanic client: 1
REVISION HISTORY:
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Section 3 - Demographic Information
ITEM NO / NAME: 3.4.1: Race 1
PURPOSE:
To indicate the first race that is self-reported by a client.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
9 = Unknown
EXPLANATION:
The method of identifying race must be self-identification by the
client. If a client reports more than one race category, then this
field should be populated first; and Items 3.4.2 “Race 2” through
Item 3.4.5 “Race 5” should be used as needed to report additional
race categories. No primary race is collected. The Race 1 field
has no significance over Race 2-5, and may simply be the first race
that is mentioned by the client.
If Item 3.3 “Hispanic or Latino origin” is not collected separately
from race, and race is reported as “Hispanic”, then race should be
reported to the CDC as 9 (Unknown) and 3.3 “Hispanic or Latino
origin” should be reported to the CDC as 1 (Yes).
The response options for this item are defined by the Office of
Management and Budget (OMB) for the collection of race and
ethnicity data. Additional information is available on the OMB Web
site at http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this
chapter (Chapter 2) in Appendix D. The code set offers a detailed
list of race concepts that can be used for data collection, and
guidance for collapsing those detailed concepts into the standard
form used in the CCDEs.
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Section 3 - Demographic Information
EXAMPLE:
If a client self-identifies as Asian: 3
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Section 3 - Demographic Information
ITEM NO / NAME: 3.4.2: Race 2
PURPOSE:
To indicate the second race that is self-reported by a client.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed when more than one race is selfreported by a client; otherwise leave blank.
CONTENTS:
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
EXPLANATION:
The method of identifying race must be self-identification by the
client. This field should be left blank unless a client reports more
than one race. No primary race is collected. The Race 1 field has
no significance over Race 2, and Race 2 has no significance over
the Race 3-5 fields. It may simply be the second race mentioned
by a client. Unknown race must be reported in the Race 1 field.
The response options for this item are defined by the Office of
Management and Budget (OMB) for the collection of race and
ethnicity data. Additional information is available on the OMB Web
site at http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this
chapter in Appendix D. The code set offers a detailed list of race
concepts that can be used for data collection, and guidance for
collapsing those detailed concepts into the standard form used in
the CCDEs.
EXAMPLE:
If a client identifies as Asian and White: Race 1 = 3 and Race 2 = 1
REVISION HISTORY:
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Section 3 - Demographic Information
ITEM NO / NAME: 3.4.3: Race 3
PURPOSE:
To indicate the third race that is self-reported by a client.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed when more than two races are selfreported by a client; otherwise leave blank.
CONTENTS:
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
EXPLANATION:
The method of identifying race must be self-identification by the
client. This field should be left blank unless a client reports more
than two races. No primary race is collected. The Race 1-2 fields
have no significance over the Race 3-5 fields. It may simply be the
third race mentioned by a client. Unknown race must be reported
in the Race 1 field.
The response options for this item are defined by the Office of
Management and Budget (OMB) for the collection of race and
ethnicity data. Additional information is available on the OMB Web
site at http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this
chapter in Appendix D. The code set offers a detailed list of race
concepts that can be used for data collection, and guidance for
collapsing those detailed concepts into the standard form used in
the CCDEs.
EXAMPLE:
If a client identifies as Asian, White and African American: Race 1
= 3; Race 2 = 1; and Race 3 = 2
REVISION HISTORY:
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Chapter 2 – CCDE Field Descriptions
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Section 3 - Demographic Information
ITEM NO / NAME: 3.4.4: Race 4
PURPOSE:
To indicate the fourth race that is self-reported by a client.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed when more than three races are
self-reported by a client; otherwise leave blank.
CONTENTS:
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
EXPLANATION:
The method of identifying race must be self-identification by the
client. This field should be left blank unless a client reports more
than three races. No primary race is collected. The Race 1-3 fields
have no significance over the Race 4-5 fields. It may simply be the
fourth race mentioned by a client. Unknown race must be reported
in the Race 1 field.
The response options for this item are defined by the Office of
Management and Budget (OMB) for the collection of race and
ethnicity data. Additional information is available on the OMB Web
site at http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this
chapter in Appendix D. The code set offers a detailed list of race
concepts that can be used for data collection, and guidance for
collapsing those detailed concepts into the standard form used in
the CCDEs.
EXAMPLE:
If a client identifies as Asian, White, African American and Alaska
Native: Race 1 = 3; Race 2 = 1; Race 3 = 2; and Race 4 = 5
REVISION HISTORY:
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Section 3 - Demographic Information
ITEM NO / NAME: 3.4.5: Race 5
PURPOSE:
To indicate the fifth race that is self-reported by a client.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed when more than four races are selfreported by a client; otherwise leave blank.
CONTENTS:
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
EXPLANATION:
The method of identifying race must be self-identification by the
client. This field should be left blank unless a client reports more
than four races. No primary race is collected. The Race 1-4 fields
have no significance over the Race 5 field. It may simply be the
fifth race mentioned by a client. No more than five races will be
reported for a client in any CCDE record. Unknown race must be
reported in the Race 1 field.
The response options for this item are defined by the Office of
Management and Budget (OMB) for the collection of race and
ethnicity data. Additional information is available on the OMB Web
site at http://www.whitehouse.gov/omb/fedreg/1997standards.html.
A Race and Ethnicity Code Set is provided at the end of this
chapter in Appendix D. The code set offers a detailed list of race
concepts that can be used for data collection, and guidance for
collapsing those detailed concepts into the standard form used in
the CCDEs.
EXAMPLE:
If a client identifies as Asian, White, African American, Alaskan
Native and Hawaiian: Race 1 = 3; Race 2 = 1; Race 3 = 2; Race 4
= 5; and Race 5 = 4
REVISION HISTORY:
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Section 3 - Demographic Information
ITEM NO / NAME: 3.5: State of residence
PURPOSE:
To indicate the FIPS code for a client’s state of residence.
LENGTH:
2
TYPE:
Numeric - right justify
SKIP PATTERN:
If known, this field should be completed; otherwise leave blank.
CONTENTS:
A 2-digit numeric code.
EXPLANATION:
State of residence must be self-reported by the client. The state
Federal Information Processing Standard (FIPS) codes are
developed by the National Institute of Standards and Technology
(NIST) and are available at
http://www.itl.nist.gov/fipspubs/fip5-2.htm. There is a code for each
state and territory.
EXAMPLE:
Client’s state of residence is Maryland: 24
REVISION HISTORY:
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Section 3 - Demographic Information
ITEM NO / NAME: 3.6 County of residence
PURPOSE:
To indicate the FIPS code for a client’s county of residence.
LENGTH:
3
TYPE:
Numeric - right justify
SKIP PATTERN:
If known, this field should be completed; otherwise leave blank.
CONTENTS:
A 3-digit numeric code relevant to the State of residence reported in
Item 3.5.
EXPLANATION:
County of residence must be self-reported by the client. The
county FIPS codes are the Federal Information Processing
Standard codes developed by the National Institute of Standards
and Technology (NIST) and are available at
http://www.itl.nist.gov/fipspubs/co-codes/states.htm. There is a 3digit code for each county in a state or territory. If your state does
not have counties, enter 999.
EXAMPLE:
Client’s county of residence is Frontier, Nebraska: 063
REVISION HISTORY:
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Section 4 - Screening History
ITEM NO / NAME: 4.1.1: Previous take-home CRC fecal test (FOBT/FIT)
PURPOSE:
To indicate if a client has previously had either a take-home Fecal
Occult Blood Test (FOBT) or Fecal Immunochemical Test (FIT).
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field is used to indicate if a client has previously had a takehome guaiac-based Fecal Occult Blood Test (FOBT) or a takehome Fecal Immunochemical Test (FIT). These are both examples
of tests looking for occult, or hidden, blood in the stool.
A FOBT is used to detect blood in stool by placing a small sample
of stool on a chemically treated card window. The client will collect
the stool sample and return the card to a laboratory or program
office, as instructed by the program. A chemical solution is then
placed on top of the sample by laboratory personnel; and if the card
window turns blue, then there is blood in the stool. A FIT also
detects blood in the stool by detecting part of the hemoglobin
molecule. FIT is performed in a similar manner as FOBT, although
the testing process is automated, but it is more specific and may
reduce the number of false positive results. Other possible terms
for FOBT may include hemoccult, guaiac, and immunochemical
FOBT (iFOBT).
This information can be self-reported by the client, or can come
from information documented in the client’s medical record.
Medical record information is preferred, if available. Fecal tests
done by a provider in an office are not acceptable and should not
be recorded in this field. If the client has had a take-home FOBT or
FIT test in the past, then complete this field as 1 (Yes). In such
cases, both the date performed (Item 4.1.2) and the test result
(Item 4.1.3) should also be reported. If the client has never had a
take-home FOBT/FIT test prior to the visit, then complete this field
as 2 (No). If the client has had a previous FOBT/FIT test within the
program (as part of a separate screening cycle), complete this field
as 1 (Yes).
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
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EXAMPLE:
If a client has previously had a take-home FOBT or FIT: 1
REVISION HISTORY:
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Revised to indicate that “This information can
be self-reported by the client, or can come from
information documented in the client’s medical
record. Medical record information is preferred,
if available”
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Chapter 2 – CCDE Field Descriptions
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Section 4 - Screening History
ITEM NO / NAME: 4.1.2: Previous take-home CRC fecal test date
PURPOSE:
To indicate the date of a client’s most recent FOBT or FIT test.
LENGTH:
6
TYPE:
Date
SKIP PATTERN:
If Item 4.1.1 “Previous take-home CRC fecal test FOBT/FIT” is 1
(Yes), then this field should be completed; otherwise leave blank.
CONTENTS:
A 6-digit date field of the form MMYYYY, where MM is a number
from 1 to 12, and YYYY is the year of the prior FOBT/FIT. If just
the year is known, then blank fill the month (e.g., 1995).
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had
more than one FOBT/FIT previously, then report the date of the
most recent FOBT/FIT test that is indicated by the client. It is
acceptable to report any date that the client can recall including the
date of the test, the date the test was returned, or the date that the
test results were received by the client.
If client is unsure of the actual month, this part of the field may be
left blank, and just the year reported. If client is unsure of the year,
they should be prompted to provide an estimate: within the last
year? Less than 3 years ago? Less than 5 years ago? The date
field can be completed with the estimated date.
EXAMPLE:
If a client’s most recent prior FOBT was May 1, 1995: 051995
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
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04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
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ITEM NO / NAME: 4.1.3: Previous take-home CRC fecal test result
PURPOSE:
To indicate the result of a client’s most recent FOBT or FIT test.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 4.1.1 “Previous take-home CRC fecal test FOBT/FIT” is 1
(Yes), then this field should be completed; otherwise leave blank.
CONTENTS:
1 = Normal/negative test
2 = Abnormal/positive test result
9 = Unknown
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had
more than one FOBT/FIT test previously, report the result of the
most recent test.
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
EXAMPLE:
If the result of the client’s most recent FOBT was positive: 2
REVISION HISTORY:
CCDE version
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1.00
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1.01
Version 1.01
April 2006
04/26/2006
Revised to indicate that “This
information can be self-reported by
the client, or can come from
information documented in the
client’s medical record. Medical
record information is preferred, if
available”
Chapter 2 – CCDE Field Descriptions
35
Section 4 - Screening History
ITEM NO / NAME: 4.2.1: Previous sigmoidoscopy
PURPOSE:
To indicate if a client has previously had a sigmoidoscopy.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field is used to indicate if a client has previously had a
sigmoidoscopy. Sigmoidoscopy is the direct visual examination of
the inside of the rectum and sigmoid colon using an instrument
called a sigmoidoscope. The client should have cleaned out their
bowels using a prescribed enema or cathartic. The test examines
the lower half of the colon. A sigmoidoscope is a lighted, flexible
tube with a camera attached to it. It is inserted into the colon to
examine the lining of the rectum, sigmoid and descending portions
of the colon. Some other possible terms for sigmoidoscopy include
sig, flex sig, and flexible sigmoidoscopy.
Rigid sigmoidoscopy or proctoscopy should not be used as an
alternative to flexible sigmoidoscopy for CRC screening.
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had a
sigmoidoscopy in the past, then complete this field as 1 (Yes). In
such cases, both the date performed (Item 4.2.2) and the test result
(Item 4.2.3) should also be reported. If the client has not had a
sigmoidoscopy prior to the visit, complete this field as 2 (No). If the
client had a previous sigmoidoscopy within the program (as part of
a separate screening cycle), complete this field as 1 (Yes).
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
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Chapter 2 – CCDE Field Descriptions
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Section 4 - Screening History
EXAMPLE:
If a client has previously had a sigmoidoscopy: 1
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
1.01
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
37
Section 4 - Screening History
ITEM NO / NAME: 4.2.2: Previous sigmoidoscopy test date
PURPOSE:
To indicate the date of a client’s most recent sigmoidoscopy.
LENGTH:
6
TYPE:
Date
SKIP PATTERN:
If Item 4.2.1 “Previous sigmoidoscopy” is 1 (Yes), then this field
should be completed; otherwise leave blank.
CONTENTS:
A 6-digit date field of the form MMYYYY, where MM is a number
from 1 to 12, and YYYY is the year of the client’s previous
sigmoidoscopy. If just the year is known, then blank fill the month
(e.g., 1995).
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had
more than one prior sigmoidoscopy, then report the date of the
most recent sigmoidoscopy procedure indicated by the client.
If client is unsure of the actual month, this part of the field may be
left blank, and just the year reported. If client is unsure of the year,
they should be prompted to provide an estimate: within the last
year? Less than 3 years ago? Less than 5 years ago? The date
field can be completed with the estimated date.
EXAMPLE:
If a client’s most recent sigmoidoscopy was May 1, 1998: 051998
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
1.01
38
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 4 - Screening History
ITEM NO / NAME: 4.2.3: Result of previous sigmoidoscopy
PURPOSE:
To indicate the result of a client’s most recent sigmoidoscopy.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 4.2.1 “Previous sigmoidoscopy” is 1 (Yes), then this field
should be completed; otherwise leave blank.
CONTENTS:
1 = Normal/negative/results other than polyp(s), tumor(s), or cancer
2 = Polyp(s)/tumor(s)/cancer
3 = Incomplete
9 = Unknown
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had
more than one prior sigmoidoscopy, then report the result of the
most recent sigmoidoscopy procedure indicated by the client.
A response of 3 (Incomplete) should mean that that sigmoidoscopy
procedure was incomplete, and a result is therefore not available.
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
EXAMPLE:
If the result of the client’s most recent sigmoidoscopy was polyps:
2
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by
the client, or can come from
information documented in the client’s
medical record. Medical record
information is preferred, if available”
1.01
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
39
Section 4 - Screening History
ITEM NO / NAME: 4.3.1: Previous colonoscopy
PURPOSE:
To indicate if a client has previously had a colonoscopy.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field is used to indicate if a client has previously had a
colonoscopy. Colonoscopy is an internal examination of the full
length of the colon using an instrument called a colonoscope. The
client should have cleaned out their bowels using a prescribed
enema or cathartic. A colonoscope is a lighted, flexible tube with a
camera attached to it. It also may be used to biopsy polyps and
lesions.
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had a
colonoscopy in the past, then complete this field as 1 (Yes). In
such cases, both the date performed (Item 4.3.2) and the test result
(Item 4.3.3) should also be reported. If the client has not had a
colonoscopy prior to the visit, complete this field as 2 (No). If the
client had a previous colonoscopy within the program (as part of a
separate screening cycle), then complete this field as 1 (Yes).
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
40
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 4 - Screening History
EXAMPLE:
If a client has not previously had a colonoscopy: 2
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
1.01
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
41
Section 4 - Screening History
ITEM NO / NAME: 4.3.2: Previous colonoscopy test date
PURPOSE:
To indicate the date of a client’s most recent colonoscopy.
LENGTH:
6
TYPE:
Date
SKIP PATTERN:
If Item 4.3.1 “Previous colonoscopy” is 1 (Yes), then this field
should be completed; otherwise leave blank.
CONTENTS:
A 6-digit date field of the form MMYYYY, where MM is a number
from 1 to 12, and YYYY is the year of the client’s previous
colonoscopy. If just the year is known, then blank fill the month
(e.g., 1998).
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had
more than one prior colonoscopy, then report the date of the most
recent colonoscopy procedure indicated by the client.
If client is unsure of the actual month, this part of the field may be
left blank, and just the year reported. If client is unsure of the year,
they should be prompted to provide an estimate: within the last
year? Less than 3 years ago? Less than 5 years ago? The date
field can be completed with the estimated date.
EXAMPLE:
If a client’s most recent colonoscopy was June 8, 1993: 061993
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
1.01
42
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 4 - Screening History
ITEM NO / NAME: 4.3.3: Result of previous colonoscopy
PURPOSE:
To indicate the result of a client’s most recent colonoscopy.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 4.3.1 “Previous colonoscopy” is 1 (Yes), then this field
should be completed; otherwise leave blank.
CONTENTS:
1 = Normal/negative/results other than polyp(s), tumor(s), or cancer
2 = Polyp(s)/tumor(s)/cancer
3 = Incomplete
9 = Unknown
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had
more than one prior colonoscopy, then report the result of the most
recent colonoscopy procedure indicated by the client.
A response of 3 (Incomplete) should mean that that colonoscopy
procedure was incomplete, and a result is therefore not available.
Incomplete examinations are those in which the endoscopist was
unable to complete the examination due to pain, inadequate bowel
preparation or client anatomy.
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
EXAMPLE:
If the result of the client’s most recent colonoscopy was normal: 1
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This information
can be self-reported by the client, or can
come from information documented in the
client’s medical record. Medical record
information is preferred, if available”
1.01
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
43
Section 4 - Screening History
ITEM NO / NAME: 4.4.1: Previous DCBE
PURPOSE:
To indicate if a client has previously had a double-contrast barium
enema (DCBE).
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field is used to indicate if a client has previously had a DCBE.
A DCBE involves a series of x-rays of the colon and rectum that are
taken after the client is given an enema with a white, chalky
solution that contains barium. The client should have previously
cleaned their bowels using a prescribed enema or cathartic. The
barium outlines the intestines on the x-rays, permitting the detection
of colon and rectal abnormalities including polyps and cancers of
the colon and rectum. Air is instilled into the colon to further define
structures. Some other terms for DCBE may include barium
enema, air-contrast barium enema, barium enema x-ray, and lower
GI series.
A single-contrast enema should not be performed as an alternative
for a double-contrast barium enema for the purposes of CRC
screening.
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had a
DCBE in the past, then complete this field as 1 (Yes). In such
cases, both the date performed (Item 4.4.2) and the prior test result
(Item 4.4.3) should also be reported. If the client has not had a
DCBE prior to the visit, then complete this field as 2 (No). If the
client has had a previous DCBE within the program (as part of a
separate screening cycle), complete this field as 1 (Yes).
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
44
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 4 - Screening History
EXAMPLE:
If a client does not know if he/she has had a prior DCBE: 9
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
1.01
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
45
Section 4 - Screening History
ITEM NO / NAME: 4.4.2: Previous DCBE test date
PURPOSE:
To indicate the date of a client’s most recent DCBE.
LENGTH:
6
TYPE:
Date
SKIP PATTERN:
If Item 4.4.1 “Previous DCBE” is 1 (Yes), then this field should be
completed; otherwise leave blank.
CONTENTS:
A 6-digit date field of the form MMYYYY, where MM is a number
from 1 to 12, and YYYY is the year of the client’s most recent
DCBE. If just the year is known, then blank fill the month (e.g.,
1998).
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had
more than one prior DCBE, then report the date of the most recent
DCBE procedure indicated by the client.
If client is unsure of the actual month, this part of the field may be
left blank, and just the year reported. If client is unsure of the year,
they should be prompted to provide an estimate: within the last
year? Less than 3 years ago? Less than 5 years ago? The date
field can be completed with the estimated date.
EXAMPLE:
If a client’s most recent DCBE was August 25, 2001: 082001
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by
the client, or can come from
information documented in the client’s
medical record. Medical record
information is preferred, if available”
1.01
46
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 4 - Screening History
ITEM NO / NAME: 4.4.3: Result of previous DCBE
PURPOSE:
To indicate the result of a client’s most recent DCBE.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 4.3.1 “Previous DCBE” is 1 (Yes), then this field should be
completed; otherwise leave blank.
CONTENTS:
1 = Normal/negative/results other than polyp(s), tumor(s), or cancer
2 = Polyp(s)/tumor(s)/cancer
3 = Incomplete
9 = Unknown
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has had
more than one prior DCBE, then report the result of the most recent
DCBE procedure indicated by the client.
A response of 3 (Incomplete) should mean that that DCBE
procedure was incomplete, and a result is therefore not available.
Incomplete examinations are those in which the radiologist was
unable to complete the examination due to pain, inadequate bowel
preparation or client anatomy.
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
EXAMPLE:
If the result of the client’s most recent DCBE was incomplete: 3
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
1.01
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
47
Section 5 - Colorectal Cancer Risk Factors
ITEM NO / NAME: 5.1.1: Personal history of CRC (colorectal cancer)
PURPOSE:
To indicate if a client has ever been diagnosed with CRC.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field is used to indicate if a client has ever been diagnosed with
colorectal cancer, which is cancer of the colon or rectum. Other
possible terms for CRC include colon cancer, rectal cancer, cancer of
the large intestine, cancer of the large bowel, and bowel cancer. Anal
cancer, or cancer of the anus, should not be reported in this field.
This information can be self-reported by the client, or can come from
information documented in the client’s medical record. Medical record
information is preferred, if available. If the client indicates that he/she
has been previously diagnosed with CRC, then this field should be
completed as 1 (Yes). In such cases, the year that the CRC was
diagnosed should be reported in Item 5.1.2. If the client has been
previously diagnosed with CRC more than once, report the year of the
most recent CRC diagnosis that is indicated by the client. If the client
has never been diagnosed with CRC prior to the visit, then complete
this field as 2 (No).
A response of 9 (Unknown) in the context of this question may mean
that the client was not asked, the answer was not recorded, the client
was unsure, or the client refused to answer the question.
EXAMPLE:
A client indicates he/she was diagnosed with CRC previously: 1
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
1.01
48
04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 5 - Colorectal Cancer Risk Factors
ITEM NO / NAME: 5.1.2: Year CRC diagnosed
PURPOSE:
To indicate the date of a client’s most recent CRC diagnosis.
LENGTH:
4
TYPE:
Date
SKIP PATTERN:
If Item 5.1.1 “Personal History of CRC” is 1 (Yes), then this field
should be completed; otherwise leave blank.
CONTENTS:
A 4-digit date field of the form YYYY to indicate the year of the
client’s most recent CRC diagnosis.
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client has been
previously diagnosed with CRC more than once, report the date of
the most recent CRC diagnosis indicated by the client.
EXAMPLE:
A client’s most recent CRC diagnosis was May 7, 2001: 2001
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
1.01
Version 1.01
April 2006
04/26/2006
Revised to indicate that “This
information can be self-reported by
the client, or can come from
information documented in the
client’s medical record. Medical
record information is preferred, if
available”
Chapter 2 – CCDE Field Descriptions
49
Section 5 - Colorectal Cancer Risk Factors
ITEM NO / NAME: 5.2.1: Personal history of polyp(s)
PURPOSE:
To specify if a client has ever been diagnosed with polyps.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field is used to indicate if a client has ever been diagnosed with
polyps of the colon or rectum. A polyp is a growth, or mass of tissue
that develops on the inside wall of a hollow organ, such as the colon.
It projects, usually on a stalk, from the lining of the colon or rectum and
can sometimes develop into cancer. Other possible terms for polyp
include growth, mass, outgrowth, adenoma, and intestinal polyps
This information can be self-reported by the client, or can come from
information documented in the client’s medical record. Medical record
information is preferred, if available. If the client indicates that he/she
has previously been diagnosed with polyps of any type, this field
should be completed as 1 (Yes). In such cases, the year that the
polyps were diagnosed should be reported in Item 5.2.2. If the client
has been previously diagnosed with polyps more than once, report the
year of the most recent polyp diagnosis that is indicated by the client.
If the client has never been diagnosed with polyps prior to the visit,
complete this field as 2 (No).
A response of 9 (Unknown) in the context of this question may mean
that the client was not asked, the answer was not recorded, the client
was unsure, or the client refused to answer the question.
EXAMPLE:
If the client has been told that they had polyps, based on a previous
exam: 1
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This information
can be self-reported by the client, or can
come from information documented in the
client’s medical record. Medical record
information is preferred, if available”
1.01
50
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 5 - Colorectal Cancer Risk Factors
ITEM NO / NAME: 5.2.2: Largest number of polyps diagnosed during a single
procedure
PURPOSE:
To indicate a client’s largest number of polyps diagnosed during a
single procedure.
LENGTH:
2
TYPE:
Numeric – right justify
SKIP PATTERN:
If Item 5.2.1 “Personal History of polyps” is 1 (Yes), then this field
should be completed; otherwise leave blank.
CONTENTS:
1 - 49 = Number of polyps
50 = ≥ 50 polyps
91 = < 10 polyps (if exact number not known)
92 = ≥ 10 polyps (if exact number not known)
99 = Unknown
EXPLANATION:
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. It is preferred that an
exact number of polyps is obtained if possible. If the client reports
an exact number of polyps that is less than fifty, then complete this
field with the exact number. If the client reports an exact number of
polyps that is fifty or greater, complete this field as 50 (≥ 50 polyps).
If the client does not know the exact number of polyps but reports
that it was less than ten, complete this field as 91 (< 10 polyps). If
the client does not know the exact number of polyps but reports
that it was ten or greater, complete this field as 92 (≥ 10 polyps).
A response of 99 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
51
Section 5 - Colorectal Cancer Risk Factors
EXAMPLE:
Client largest number of polyps diagnosed during a single
procedure is an estimate of less than ten polyps: 91
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by the
client, or can come from information
documented in the client’s medical
record. Medical record information is
preferred, if available”
1.01
52
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 5 - Colorectal Cancer Risk Factors
ITEM NO / NAME: 5.2.3: Were any of these polyps adenomatous?
PURPOSE:
To indicate if a client has ever been diagnosed with adenomatous
polyps.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 5.2.1 “Personal History of polyps” is 1 (Yes), then this field
should be completed; otherwise leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
There are two types of polyps commonly identified: adenomatous
polyps (also known as adenomas) and hyperplastic polyps. The
purpose of this field is to collect information about adenomatous
polyps only, which are pre-cancerous or pre-malignant polyps.
This information can be self-reported by the client, or can come
from information documented in the client’s medical record. Medical
record information is preferred, if available. If the client indicates
that he/she has previously been diagnosed with adenomatous
polyps, then this field should be completed as 1 (Yes). The
diagnosis of adenomatous polyps can be from any previous test or
visit; not just the most recent diagnosis. If the client has never
been diagnosed with adenomatous polyps before, complete this
field as 2 (No).
Along with adenomatous and hyperplastic polyps, other types of
polyps do exist, including inflammatory polyps. If only a type of
polyp other than an adenomatous polyp is reported, this field
should be completed as 2 (No).
A response of 9 (Unknown) in the context of this question may
mean that the client was not asked, the answer was not recorded,
the client was unsure, or the client refused to answer the question.
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
53
Section 5 - Colorectal Cancer Risk Factors
EXAMPLE:
A client indicates no prior diagnosis of adenomatous polyps: 2
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that “This
information can be self-reported by
the client, or can come from
information documented in the client’s
medical record. Medical record
information is preferred, if available”
1.01
54
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 5 - Colorectal Cancer Risk Factors
ITEM NO / NAME: 5.3: High risk due to family history of CRC
PURPOSE:
To indicate if a client is at high risk for CRC due to family history.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field is used to indicate if a client is considered by the program
to be at high risk due to a family history of CRC. Each program has
its own documented definition of high risk due to family history of
CRC.
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
55
Section 6 - Screening and Diagnostic Tests Provided
ITEM NO / NAME: 6.0: Initial test recommended
PURPOSE:
To indicate the initial test recommended for a client by the program
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Take-home Fecal Occult Blood Test (FOBT)
2 = Take-home Fecal Immunochemical Test (FIT)
3 = Sigmoidoscopy
4 = Colonoscopy
5 = Double-contrast Barium Enema (DCBE)
9 = Unknown
EXPLANATION:
This field should report the recommended procedure for this client
that will begin the screening cycle. This is the test recommended
by the program.
In some cases, the initial test recommended and the actual first test
received (Item 6.1.01) may not be the same. This is acceptable.
Analysis will be performed on the data to examine the relationship
between the initial test recommended and the actual first test
performed.
EXAMPLE:
If it is recommended that the client receive a sigmoidoscopy: 3
REVISION HISTORY:
56
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 6 - Screening and Diagnostic Tests Provided
ITEM NO / NAME: 6.1.0: Indication for 1st test provided
PURPOSE:
This is the indication for the actual test provided, reported in 6.1.01
“First test provided”.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Screening
2 = Surveillance after a positive colonoscopy
9 = Unknown
EXPLANATION:
The field should be used to indicate the purpose for the first test
given to the client. For this program, “provided” is the same as
“paid for”, therefore, this could include a screening FOBT/FIT that
was mailed, but not returned.
A screening test (1) is a test provided for someone who has no
symptoms, and may have never been screened, or may have had a
previous negative screening test and is due for their next re-screen.
A surveillance test (2) is a test (typically a colonoscopy) done at
more frequent intervals than screening to evaluate someone who
has a known history of colorectal polyps or colorectal cancer, to
look for recurrence of these. The appropriate intervals for
surveillance tests can be found in published guidelines.
EXAMPLE:
If the purpose of the first test provided is for screening: 1
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ITEM NO / NAME: 6.1.01: First test provided
PURPOSE:
To indicate the actual first test provided through the program. For
the purposes of this study “provided” = “paid for”.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Take-home Fecal Occult Blood Test (FOBT)
2 = Take-home Fecal Immunochemical Test (FIT)
3 = Sigmoidoscopy
4 = Colonoscopy
5 = Double-contrast Barium Enema (DCBE)
EXPLANATION:
This field should be reported with the actual first test provided by
the program. It is possible that this first test provided is not the
same as the initial test recommended (Item 6.0).
EXAMPLE:
If the first test actually provided to the client is a sigmoidoscopy: 3
REVISION HISTORY:
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ITEM NO / NAME: 6.1.02: Date of 1st test
PURPOSE:
To specify the date of the first test.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
This field should always be completed.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a value
from 01 to 12, DD is a value from 01 to 31, and YYYY is the year of
the procedure. If just the year is known, blank fill the month and
day. If just the year and month are known, blank fill the day (e.g.
08 2006). This field should not be left completely blank.
EXPLANATION:
This field captures the date that the first test was performed. If the
test is a take-home FOBT or FIT, then report the date that the test
was processed.
If Item 6.1.05 “Results of take-home FOBT/FIT” is 3 (Refused), then
complete this field with an administrative close-out date as defined
by your program.
If Item 6.1.05 “Results of take-home FOBT/FIT” is 4 (Did Not
Return Card), then complete this field with the date that the
FOBT/FIT kit was distributed to the client.
EXAMPLE:
If a colonoscopy was performed on August 1, 2006: 08012006
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Section 6 - Screening and Diagnostic Tests Provided
ITEM NO / NAME: 6.1.03: Provider specialty
PURPOSE:
To report the specialty of the clinician providing the first test.
LENGTH:
2
TYPE:
Numeric - right justify
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = General practitioner
2 = Internist
3 = Family practitioner
4 = Gastroenterologist
5 = General surgeon
6 = Colorectal surgeon
7 = Licensed practical nurse
8 = Registered nurse
9 = Nurse practitioner
10 = Physician assistant
11 = Administrator, if FOBT/FIT mailed by non-clinician
99 = Unknown
EXPLANATION:
This field should capture the medical practice specialty of the
provider who performed or provided the first test reported in Item
6.1.01. If the first test is an FOBT/FIT, capture the specialty of the
individual that made the assessment that an FOBT/FIT should be
provided to the client, not the individual that mailed out the card.
EXAMPLE:
If the provider specialty for the first test is a general surgeon: 5
REVISION HISTORY:
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ITEM NO / NAME: 6.1.04: Clinical practice site
PURPOSE:
To report the type of clinical practice for the provider reported in
6.1.03.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Doctor’s office
2 = Ambulatory endoscopy/surgery center
3 = Hospital
4 = Health clinic
5 = Administrator, if FOBT/FIT mailed by non-clinician
9 = Unknown
EXPLANATION:
This field should report the type of clinical practice for the provider
reported in Item 6.1.03 (Provider specialty).
EXAMPLE:
If the provider’s practice is located in a hospital: 3
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ITEM NO / NAME: 6.1.05: Result of take-home FOBT/FIT
PURPOSE:
To specify the results of an FOBT or FIT, if this test was the first
test provided. This field is not available for the second (6.2.05),
third (6.3.05), or fourth (6.4.05) test due to FOBT/FIT not being an
allowable procedure as a subsequent test within a cycle (Items
6.2.01, 6.3.01, and 6.4.01).
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.1.01 = 1 (Take-home
FOBT) or 2 (Take-home FIT); otherwise, leave blank.
CONTENTS:
1 = Normal/negative
2 = Positive
3 = Refused
4 = Did not return card
5 = Pending
9 = Unknown
EXPLANATION:
If Item 6.1.01 = 1 (Take-home FOBT) or 2 (Take-home FIT), then
this field should be completed, otherwise, leave blank.
If a response of 3 (Refused) is indicated, then Item 6.1.02 “Date of
1st test” should be completed with an administrative close-out date
as defined by your program.
If a response of 4 (Did not return card) is indicated, then Item
6.1.02 “Date of 1st test” should be completed with the date that the
FOBT/FIT kit was distributed to the client. Item 6.1.13
“Recommended next follow-up” should be reported as 8 (None) and
Item 9.1 “Status of Diagnosis” should be reported as 9 (Unknown).
If the chart records any gradation of positive (i.e. “weakly positive”
or “slightly positive”), the response should be recorded as Positive
(2).
EXAMPLE:
If result of the take-home FOBT was positive: 3
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ITEM NO / NAME: 6.1.06: Results of endoscopy or DCBE
PURPOSE:
To specify the results of a sigmoidoscopy, colonoscopy or DCBE, if
it was the first test performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.1.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE).
CONTENTS:
1 = Normal/negative/diverticulosis/hemorrhoids
2 = Other finding not suggestive of cancer/polyp(s)
3 = Polyp(s)/suspicious for cancer/presumed cancer
4 = No findings/inconclusive
5 = Pending
9 = Unknown
EXPLANATION:
This field should be completed if Item 6.1.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE), otherwise, leave blank.
If more than one result is noted on the medical chart, then report
the most severe.
Results from an incomplete or inconclusive test should always be
coded as 4 (No Findings/inconclusive), regardless if any specific
findings were noted. An incomplete test may be due to patient
discomfort or distress. Inconclusive findings may be due to
obstruction, inadequate preparation and retained fecal material,
physician fatigue or cecum not reached. Any specific findings that
were noted from an incomplete or inconclusive test should be
captured and reported elsewhere in the CCDE, including reporting
in Sections 6 “Screening and Diagnostic Tests Provided” and
Section 7 “Diagnosis Information for All Polyps/Lesions” on
polyps/lesions identified or removed. Another screening test should
be recommended following an incomplete or inconclusive test.
EXAMPLE:
If result of the DCBE was suspicious for cancer: 3
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Section 6 - Screening and Diagnostic Tests Provided
ITEM NO / NAME: 6.1.07: Was the bowel preparation considered adequate by the
clinician performing the endoscopy or DCBE?
PURPOSE:
To indicate the adequacy of the bowel preparation for a
sigmoidoscopy, colonoscopy or DCBE, if it was the first test
performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.1.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE).
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field should be completed if Item 6.1.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE), otherwise, leave blank.
Adequacy of the bowel preparation will be determined by the
clinician performing the test. A response of 1 (Yes) can only be
reported if the procedure report explicitly states that the bowel
preparation was adequate, otherwise report 9 (Unknown).
EXAMPLE:
If procedure report indicates adequate bowel preparation: 1
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ITEM NO / NAME: 6.1.08: Was the cecum reached during the initial colonoscopy?
PURPOSE:
To indicate whether or not the procedure notes report that the
cecum was reached during the colonoscopy, if it was the first
procedure performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.1.01 = 4 (Colonoscopy);
otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
If the first procedure performed was a colonoscopy, indication of
whether the cecum was reached during the procedure should be
reported.
The procedure report must explicitly state that the cecum was
reached during the colonoscopy in order to report 1 (Yes);
otherwise report 9 (Unknown).
EXAMPLE:
If cecum was not reached: 2
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ITEM NO / NAME: 6.1.09: Complications of endoscopy or DCBE?
PURPOSE:
To indicate whether there were complications due to the
sigmoidoscopy, colonoscopy or DCBE, if it was the first test
performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.1.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE), otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No/unknown
EXPLANATION:
If Item 6.1.01 = 3 (Sigmoidoscopy), 4 (Colonoscopy) or 5 (DCBE),
indicate whether or not complications occurred from the procedure
which required medical attention.
If complications = 1 (Yes), then the complication should be reported
on the Adverse Events Reporting form and submitted to the CDC
on a quarterly basis, as detailed in the Adverse Events Reporting
Form (Appendix E).
If the client is hospitalized because of an immediate complication,
please notify your consultation team at CDC with 72 hours of the
hospitalization by email. You should then send a completed
Adverse Events Report Form to the CDC within five (5) days.
Please see the Adverse Events Reporting Form (Appendix E) for
further guidance.
EXAMPLE:
If rectal bleeding occurred 3 days after a procedure: 1
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ITEM NO / NAME: 6.1.10: Was a biopsy/polypectomy performed during the
endoscopy?
PURPOSE:
To indicate if biopsy or polypectomy was performed during the
sigmoidoscopy or colonoscopy.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.1.01 is 3 (Sigmoidoscopy)
or 4 (Colonoscopy); otherwise, it should be blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field should only be completed if the first test provided is either
a colonoscopy or sigmoidoscopy.
EXAMPLE:
If a polypectomy was performed during a colonoscopy: 1
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Section 6 - Screening and Diagnostic Tests Provided
ITEM NO / NAME: 6.1.11: Number of specimens sent to pathology (from
endoscopy)
PURPOSE:
To report the actual number of specimens removed during a biopsy
or polypectomy, and sent to pathology.
LENGTH:
2
TYPE:
Numeric – right justified
SKIP PATTERN:
This field should be completed if Item 6.1.01 was 3
(Sigmoidoscopy) or 4 (Colonoscopy) AND Item 6.1.10
(Biopsy/polypectomy performed) is 1 (Yes); otherwise, it should be
blank.
CONTENTS:
0 = Biopsy performed, no specimens sent
1 = One
2 = Two specimens
…
97 = Ninety-seven
98 = ≥ Ninety-eight
99 = Unknown
EXPLANATION:
The actual number of specimens sent to pathology should be
acquired and reported. If a biopsy/polypectomy was performed, but
no specimens were sent to pathology (e.g. specimen
contaminated), code 0 (Biopsy performed, no specimen sent).
When more than 98 specimens are collected during the
colonoscopy/sigmoidoscopy, report 98 (≥ 98 specimens).
If it is unknown whether any specimens were sent to pathology,
code 99 (Unknown). If the exact number of specimens sent to
pathology is unknown, code 99 (Unknown).
This field includes samples removed entirely or in part. If a single
polyp is removed piecemeal, report the number of specimens, not
the number of polyps.
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EXAMPLE:
If a biopsy was performed during a colonoscopy and 6 specimens
were sent to pathology: 6
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ITEM NO / NAME: 6.1.12: Completeness of polyp removal (from colonoscopy).
PURPOSE:
To indicate if polyps were completely removed during the first test,
if it was a colonoscopy. Do not complete this field if no polyps were
identified.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.1.01 = 4 (Colonoscopy)
and Item 6.1.06 = 3 (Polyps/suspicious for cancer/presumed
cancer) and Item 7.0 ≠ 0 (No polyps/lesions).
This field should be completed if Item 6.1.01 = 4 (Colonoscopy)
and Item 6.1.06 = 4 (No findings/inconclusive) and Item 7.0 ≠ 0 (No
polyps/lesions).
Otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
The intent of this field is to report if the colon was cleared of all
polyps noted during the colonoscopy. This field should only be
completed if the first test performed is a colonoscopy and polyps
were identified. Do not complete this field if no polyps were
identified.
If 6.1.06 = 3 and 7.0 ≠ 0; or
If 6.1.06 = 4 and 7.0 ≠ 0, then:
•
•
•
If all polyps noted during colonoscopy were removed, code 1
(Yes)
If all polyps noted were not removed, code 2 (No)
If no polyps were seen or suspected, code 9 (Unknown)
If 6.1.06 ≠ 3 or 4, then leave blank.
If this field is coded as 2 (No) or 9 (Unknown), and a second
colonoscopy is performed within the cycle to complete the removal
of polyps, see Item 9.2 “Final diagnosis” and Item 9.3 “Date of
diagnosis” for guidance on how to report histological findings.
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EXAMPLE:
If all polyps were completely removed: 1
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Section 6 - Screening and Diagnostic Tests Provided
ITEM NO / NAME: 6.1.13: Recommended next follow-up procedure within this
cycle after 1st test.
PURPOSE:
To indicate the next recommended procedure following the
completion of the first test.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to complete diagnosis
8 = None (cycle is complete)
EXPLANATION:
Once the first test is completed, the next recommended procedure
within the screening cycle should be reported. The next
recommended test within the screening cycle would either be a
diagnostic test to follow-up a positive initial screening test or
another screening test where the first screening test was
incomplete or inconclusive.
If the next recommended procedure for the client is surgery,
indicate 4 (Surgery). Items 8.1 and 8.2 should then be completed,
along with any final diagnosis and treatment data where applicable.
No further procedures (6.2.01, 6.3.01 or 6.4.01) should be reported.
Items 6.2.01, 6.3.01 and 6.4.01 will be completed with 0 (None).
If the initial screening test was normal and the next test
recommended is a screening exam (FOBT or FIT), indicate 8
(None). The screening cycle would be completed and the new
screening test will begin a new CCDE record. Items 6.2.01, 6.3.01
and 6.4.01 will be completed with 0 (None)
EXAMPLE:
If a DCBE is recommended as the next procedure within this clients
“cycle”: 3
REVISION HISTORY:
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ITEM NO / NAME: 6.2.01: 2nd Test provided
PURPOSE:
To indicate the actual second test provided through the program.
For the purposes of this study “provided” = “paid for”.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
0 = None
3 = Sigmoidoscopy
4 = Colonoscopy
5 = Double-contrast barium enema (DCBE)
EXPLANATION:
Report the next test provided. Only funded colorectal diagnostic
tests should be reported in the CCDEs. If a non-funded test is
provided (e.g. an MRI), then that test should not be reported in the
CCDEs. If the non-funded test is the only additional test performed,
then this field should be completed as 0 (None).
This test should match the test reported in 6.1.13, however it is
understood that client compliance may dictate that they will not be
the same.
If a second test was not performed, indicate 0 (None), and leave
items 6.2.03 through 6.2.13 blank.
The second test may not be an FOBT or FIT. These exams are
considered screening tests, which would begin a new record.
EXAMPLE:
If the second test actually provided to the client is a sigmoidoscopy:
3
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ITEM NO / NAME: 6.2.02: Date of 2nd test
PURPOSE:
To specify the date of the second test.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
This field should be completed if Item 6.2.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a value
from 01 to 12, DD is a value from 01 to 31, and YYYY is the year of
the procedure. If just the year is known, blank fill the month and
day. If just the year and month are known, blank fill the day (e.g.
08 2006). This field should not be left completely blank.
EXPLANATION:
This field captures the date that the second test was performed.
EXAMPLE:
If a colonoscopy was performed on August 1, 2006: 08012006
REVISION HISTORY:
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ITEM NO / NAME: 6.2.03: Provider specialty
PURPOSE:
To report the specialty of the clinician providing the second test.
LENGTH:
2
TYPE:
Numeric, right justify.
SKIP PATTERN:
This field should be completed if Item 6.2.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = General practitioner
2 = Internist
3 = Family practitioner
4 = Gastroenterologist
5 = General surgeon
6 = Colorectal surgeon
7 = Licensed practical nurse
8 = Registered nurse
9 = Nurse practitioner
10 = Physician assistant
99 = Unknown
EXPLANATION:
This field should capture the medical practice specialty of the
provider who performed or provided the second test reported in
Item 6.2.01.
EXAMPLE:
If the provider specialty for the second test is a general surgeon: 5
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ITEM NO / NAME: 6.2.04: Clinical practice site
PURPOSE:
To report the type of clinical practice for the provider reported in
6.2.03.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.2.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Doctor’s office
2 = Ambulatory endoscopy/surgery center
3 = Hospital
4 = Health clinic
9 = Unknown
EXPLANATION:
This field should report the type of clinical practice for the provider
reported in Item 6.2.03 (Provider specialty).
EXAMPLE:
If the provider’s practice is located in a hospital: 3
REVISION HISTORY:
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ITEM NO / NAME: 6.2.06: Results of endoscopy or DCBE
PURPOSE:
To specify the results of a sigmoidoscopy, colonoscopy or DCBE, if
it was the second test performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.2.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Normal/negative/diverticulosis/hemorrhoids
2 = Other finding not suggestive of cancer/polyp(s)
3 = Polyp(s)/suspicious for cancer/presumed cancer
4 = No findings/inconclusive
5 = Pending
9 = Unknown
EXPLANATION:
If more than one result is noted on the medical chart, then report
the most severe.
Results from an incomplete or inconclusive test should always be
coded as 4 (No Findings/inconclusive), regardless if any specific
findings were noted. An incomplete test may be due to patient
discomfort or distress. Inconclusive findings may be due to
obstruction, inadequate preparation and retained fecal material,
physician fatigue or cecum not reached. Any specific findings that
were noted from an incomplete or inconclusive test should be
captured and reported elsewhere in the CCDE, including reporting
in Sections 6 “Screening and Diagnostic Tests Provided” and
Section 7 “Diagnosis Information for All Polyps/Lesions” on
polyps/lesions identified or removed. Another screening test should
be recommended following an incomplete or inconclusive test.
EXAMPLE:
If result of the DCBE was suspicious for cancer: 3
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ITEM NO / NAME: 6.2.07: Was the bowel preparation considered adequate by the
clinician performing the endoscopy or DCBE?
PURPOSE:
To indicate the adequacy of the bowel preparation for a
sigmoidoscopy, colonoscopy or DCBE, if it was the second test
performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.2.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
Adequacy of the bowel preparation will be determined by the
clinician performing the test. A response of 1 (Yes) can only be
reported if the procedure report explicitly states that the bowel
preparation was adequate, otherwise report 9 (Unknown).
EXAMPLE:
If procedure report indicates adequate bowel preparation: 1
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ITEM NO / NAME: 6.2.08: Was the cecum reached during the colonoscopy?
PURPOSE:
To indicate whether or not the procedure notes report that the
cecum was reached during the colonoscopy, if it was the second
procedure performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.2.01 = 4 (Colonoscopy);
otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
If the second procedure performed was a colonoscopy, indication of
whether the cecum was reached during the procedure should be
reported.
The procedure report must explicitly state that the cecum was
reached during the colonoscopy in order to report 1 (Yes);
otherwise report 9 (Unknown).
EXAMPLE:
If cecum was not reached: 2
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ITEM NO / NAME: 6.2.09: Complications of endoscopy or DCBE.
PURPOSE:
To indicate whether there were complications due to the
sigmoidoscopy, colonoscopy or DCBE, if it was the second test
performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.2.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE), otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No/unknown
EXPLANATION:
If Item 6.2.01 = 3 (Sigmoidoscopy), 4 (Colonoscopy) or 5 (DCBE),
indicate whether or not complications occurred from the procedure
which required medical attention.
If complications = 1 (Yes), then the complication should be reported
on the Adverse Events Reporting form and submitted to the CDC
on a quarterly basis, as detailed in the Adverse Events Reporting
Form (Appendix E).
If the client is hospitalized because of an immediate complication,
please notify your consultation team at CDC with 72 hours of the
hospitalization by email. You should then send a completed
Adverse Events Report Form to the CDC within five (5) days.
Please see the Adverse Events Reporting Form (Appendix E) for
further guidance.
EXAMPLE:
If rectal bleeding occurred 3 days after a procedure: 1
REVISION HISTORY:
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ITEM NO / NAME: 6.2.10: Was a biopsy/polypectomy performed during the
endoscopy?
PURPOSE:
To indicate if biopsy or polypectomy was performed during the
sigmoidoscopy or colonoscopy.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.2.01 is 3 (Sigmoidoscopy)
or 4 (Colonoscopy); otherwise, it should be blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field should only be completed if the second test provided is
either a colonoscopy or sigmoidoscopy.
EXAMPLE:
If a polypectomy was performed during a colonoscopy: 1
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ITEM NO / NAME: 6.2.11: Number of specimens sent to pathology (from
endoscopy)
PURPOSE:
To report the actual number of specimens removed during a biopsy
or polypectomy, and sent to pathology.
LENGTH:
2
TYPE:
Numeric – right justified
SKIP PATTERN:
This field should be completed if Item 6.2.01 was 3
(Sigmoidoscopy) or 4 (Colonoscopy) AND Item 6.2.10
(Biopsy/polypectomy performed) is 1 (Yes); otherwise, it should be
blank.
CONTENTS:
0 = Biopsy performed, no specimens sent
1 = One
2 = Two specimens
…
97 = Ninety-seven
98 = ≥ Ninety-eight
99 = Unknown
EXPLANATION:
The actual number of specimens sent to pathology should be
acquired and reported. If a biopsy/polypectomy was performed, but
no specimens were sent to pathology (e.g. specimen
contaminated), code 0 (Biopsy performed, no specimen sent).
When more than 98 specimens are collected during the
colonoscopy/sigmoidoscopy, report 98 (≥ 98 specimens).
If it is unknown whether any specimens were sent to pathology,
code 99 (Unknown). If the exact number of specimens sent to
pathology is unknown, code 99 (Unknown).
This field includes samples removed entirely or in part. If a single
polyp is removed piecemeal, report the number of specimens, not
the number of polyps.
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EXAMPLE:
If a biopsy was performed during a colonoscopy and 6 specimens
were sent to pathology: 6
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ITEM NO / NAME: 6.2.12: Completeness of polyp removal (from colonoscopy).
PURPOSE:
To indicate if polyps were completely removed during the second
test, if it was a colonoscopy. Do not complete this field if no polyps
were identified.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.2.01 = 4 (Colonoscopy)
and Item 6.2.06 = 3 (Polyps/suspicious for cancer/presumed
cancer) and Item 7.0 ≠ 0 (No polyps/lesions).
This field should be completed if Item 6.2.01 = 4 (Colonoscopy)
and Item 6.2.06 = 4 (No findings/inconclusive) and Item 7.0 ≠ 0 (No
polyps/lesions).
Otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
The intent of this field is to report if the colon was cleared of all
polyps noted during the colonoscopy. This field should only be
completed if the second test performed is a colonoscopy and
polyps were identified. Do not complete this field if no polyps were
identified.
If 6.2.06 = 3 and 7.0 ≠ 0; or
If 6.2.06 = 4 and 7.0 ≠ 0, then:
•
•
•
If all polyps noted during colonoscopy were removed, code 1
(Yes)
If all polyps noted were not removed, code 2 (No)
If no polyps were seen or suspected, code 9 (Unknown)
If 6.2.06 ≠ 3 or 4 then leave blank.
If this field is coded as 2 (No) or 9 (Unknown), and a second
colonoscopy is performed within the cycle to complete the removal
of polyps, see Item 9.2 “Final diagnosis” and Item 9.3 “Date of
diagnosis” for guidance on how to report histological findings.
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EXAMPLE:
If all polyps were completely removed: 1
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ITEM NO / NAME: 6.2.13: Recommended next follow-up procedure within this
cycle after 2nd test.
PURPOSE:
To indicate the next recommended procedure following the
completion of the second test.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to complete diagnosis*
8 = None (cycle is complete)
EXPLANATION:
Once the second test is completed, the next recommended
procedure to be completed within the screening cycle to rule out
cancer, or not, should be reported.
If the next recommended procedure for the client is surgery,
indicate 4 (Surgery). Items 8.1 and 8.2 should then be completed,
along with any final diagnosis and treatment data where applicable.
No further procedures (6.3.01, 6.4.01) should be reported. Items
6.3.01 and 6.4.01 will be completed with 0 (None).
If the next test recommended is a screening exam (FOBT or FIT),
indicate 8 (None). The new screening test will begin a new CCDE
record. Items 6.3.01 and 6.4.01 will be completed with 0 (None).
EXAMPLE:
If a DCBE is recommended as the next procedure within this clients
“cycle”: 3
REVISION HISTORY:
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ITEM NO / NAME: 6.3.01: 3rd Test provided
PURPOSE:
To indicate the actual third test provided through the program. For
the purposes of this study “provided” = “paid for”.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
0 = None
3 = Sigmoidoscopy
4 = Colonoscopy
5 = Double-contrast barium enema (DCBE)
EXPLANATION:
Report the next test performed. Only funded colorectal diagnostic
tests should be reported in the CCDEs. If a non-funded test is
provided (e.g. an MRI), then that test should not be reported in the
CCDEs. If the non-funded test is the only additional test performed,
then this field should be completed as 0 (None).
This test should match the test reported in 6.2.13, however it is
understood that client compliance may dictate that they will not be
the same.
If a third test was not performed, indicate 0 (None), and leave items
6.3.03 through 6.3.13 blank.
The third test may not be an FOBT or FIT. These exams are
considered screening tests, which would begin a new record.
EXAMPLE:
If the third test actually provided to the client is a sigmoidoscopy: 3
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ITEM NO / NAME: 6.3.02: Date of 3rd test
PURPOSE:
To specify the date of the third test.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
This field should be completed if Item 6.3.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a value
from 01 to 12, DD is a value from 01 to 31, and YYYY is the year of
the procedure. If just the year is known, blank fill the month and
day. If just the year and month are known, blank fill the day (e.g.
08 2006). This field should not be left completely blank.
EXPLANATION:
This field captures the date that the third test was performed.
EXAMPLE:
If a colonoscopy was performed on August 1, 2006: 08012006
REVISION HISTORY:
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ITEM NO / NAME: 6.3.03: Provider specialty
PURPOSE:
To report the specialty of the clinician providing the third test.
LENGTH:
2
TYPE:
Numeric, right justify.
SKIP PATTERN:
This field should be completed if Item 6.3.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = General practitioner
2 = Internist
3 = Family practitioner
4 = Gastroenterologist
5 = General surgeon
6 = Colorectal surgeon
7 = Licensed practical nurse
8 = Registered nurse
9 = Nurse practitioner
10 = Physician assistant
99 = Unknown
EXPLANATION:
This field should capture the medical practice specialty of the
provider who performed or provided the third test reported in Item
6.3.01.
EXAMPLE:
If the provider specialty for the third test is a general surgeon: 5
REVISION HISTORY:
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ITEM NO / NAME: 6.3.04: Clinical practice site
PURPOSE:
To report the type of clinical practice for the provider reported in
6.3.03.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.3.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Doctor’s office
2 = Ambulatory endoscopy/surgery center
3 = Hospital
4 = Health clinic
9 = Unknown
EXPLANATION:
This field should report the type of clinical practice for the provider
reported in Item 6.3.03 (Provider specialty).
EXAMPLE:
If the provider’s practice is located in a hospital: 3
REVISION HISTORY:
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ITEM NO / NAME: 6.3.06: Results of endoscopy or DCBE
PURPOSE:
To specify the results of a sigmoidoscopy, colonoscopy or DCBE, if
it was the third test performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.3.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Normal/negative/diverticulosis/hemorrhoids
2 = Other finding not suggestive of cancer/polyp(s)
3 = Polyp(s)/suspicious for cancer/presumed cancer
4 = No findings/inconclusive
5 = Pending
9 = Unknown
EXPLANATION:
If more than one result is noted on the medical chart, then report
the most severe.
Results from an incomplete or inconclusive test should always be
coded as 4 (No Findings/inconclusive), regardless if any specific
findings were noted. An incomplete test may be due to patient
discomfort or distress. Inconclusive findings may be due to
obstruction, inadequate preparation and retained fecal material,
physician fatigue or cecum not reached. Any specific findings that
were noted from an incomplete or inconclusive test should be
captured and reported elsewhere in the CCDE, including reporting
in Sections 6 “Screening and Diagnostic Tests Provided” and
Section 7 “Diagnosis Information for All Polyps/Lesions” on
polyps/lesions identified or removed. Another screening test should
be recommended following an incomplete or inconclusive test.
EXAMPLE:
If result of the DCBE was suspicious for cancer: 3
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ITEM NO / NAME: 6.3.07: Was the bowel preparation considered adequate by the
clinician performing the endoscopy or DCBE?
PURPOSE:
To indicate the adequacy of the bowel preparation for a
sigmoidoscopy, colonoscopy or DCBE, if it was the third test
performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.3.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
Adequacy of the bowel preparation will be determined by the
clinician performing the test. A response of 1 (Yes) can only be
reported if the procedure report explicitly states that the bowel
preparation was adequate, otherwise report 9 (Unknown).
EXAMPLE:
If procedure report indicates adequate bowel preparation: 1
REVISION HISTORY:
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ITEM NO / NAME: 6.3.08: Was the cecum reached during the colonoscopy?
PURPOSE:
To indicate whether or not the procedure notes report that the
cecum was reached during the colonoscopy, if it was the third
procedure performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.3.01 = 4 (Colonoscopy);
otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
If the 3rd procedure performed was a colonoscopy, indication of
whether the cecum was reached during the procedure should be
reported.
The procedure report must explicitly state that the cecum was
reached during the colonoscopy in order to report 1 (Yes);
otherwise report 9 (Unknown).
EXAMPLE:
If cecum was not reached: 2
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ITEM NO / NAME: 6.3.09: Complications of endoscopy or DCBE?
PURPOSE:
To indicate whether there were complications due to the
sigmoidoscopy, colonoscopy or DCBE, if it was the third test
performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.3.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE), otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No/unknown
EXPLANATION:
If Item 6.3.01 = 3 (Sigmoidoscopy), 4 (Colonoscopy) or 5 (DCBE),
indicate whether or not complications occurred from the procedure
which required medical attention.
If complications = 1 (Yes), then the complication should be reported
on the Adverse Events Reporting form and submitted to the CDC
on a quarterly basis, as detailed in the Adverse Events Reporting
Form (Appendix E).
If the client is hospitalized because of an immediate complication,
please notify your consultation team at CDC with 72 hours of the
hospitalization by email. You should then send a completed
Adverse Events Report Form to the CDC within five (5) days.
Please see the Adverse Events Reporting Form (Appendix E) for
further guidance.
EXAMPLE:
If rectal bleeding occurred 3 days after a procedure: 1
REVISION HISTORY:
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ITEM NO / NAME: 6.3.10: Was a biopsy/polypectomy performed during the
endoscopy?
PURPOSE:
To indicate if biopsy or polypectomy was performed during the
sigmoidoscopy or colonoscopy.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.3.01 is 3 (Sigmoidoscopy)
or 4 (Colonoscopy); otherwise, it should be blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field should only be completed if the third test provided is
either a colonoscopy or sigmoidoscopy.
EXAMPLE:
If a polypectomy was performed during a colonoscopy: 1
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ITEM NO / NAME: 6.3.11: Number of specimens sent to pathology (from
endoscopy)
PURPOSE:
To report the actual number of specimens removed during a biopsy
or polypectomy, and sent to pathology.
LENGTH:
2
TYPE:
Numeric – right justified
SKIP PATTERN:
This field should be completed if Item 6.3.01 was 3
(Sigmoidoscopy) or 4 (Colonoscopy) AND Item 6.3.10
(Biopsy/polypectomy performed) is 1 (Yes); otherwise, it should be
blank.
CONTENTS:
0 = Biopsy performed, no specimens sent
1 = One
2 = Two specimens
…
97 = Ninety-seven
98 = ≥ Ninety-eight
99 = Unknown
EXPLANATION:
The actual number of specimens sent to pathology should be
acquired and reported. If a biopsy/polypectomy was performed, but
no specimens were sent to pathology (e.g. specimen
contaminated), code 0 (Biopsy performed, no specimen sent).
When more than 98 specimens are collected during the
colonoscopy/sigmoidoscopy, report 98 (≥ 98 specimens).
If it is unknown whether any specimens were sent to pathology,
code 99 (Unknown). If the exact number of specimens sent to
pathology is unknown, code 99 (Unknown).
This field includes samples removed entirely or in part. If a single
polyp is removed piecemeal, report the number of specimens, not
the number of polyps.
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EXAMPLE:
If a biopsy was performed during a colonoscopy and 6 specimens
were sent to pathology: 6
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ITEM NO / NAME: 6.3.12: Completeness of polyp removal (from colonoscopy).
PURPOSE:
To indicate if polyps were completely removed during the third test,
if it was a colonoscopy. Do not complete this field if no polyps were
identified.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.3.01 = 4 (Colonoscopy)
and Item 6.3.06 = 3 (Polyps/suspicious for cancer/presumed
cancer) and Item 7.0 ≠ 0 (No polyps/lesions).
This field should be completed if Item 6.3.01 = 4 (Colonoscopy)
and Item 6.3.06 = 4 (No findings/inconclusive) and Item 7.0 ≠ 0 (No
polyps/lesions).
Otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
The intent of this field is to report if the colon was cleared of all
polyps noted during the colonoscopy. This field should only be
completed if the third test performed is a colonoscopy and polyps
were identified. Do not complete this field if no polyps were
identified.
If 6.3.06 = 3 and 7.0 ≠ 0; or
If 6.3.06 = 4 and 7.0 ≠ 0, then:
•
•
•
If all polyps noted during colonoscopy were removed, code 1
(Yes)
If all polyps noted were not removed, code 2 (No)
If no polyps were seen or suspected, code 9 (Unknown)
If 6.3.06 ≠ 3 or 4 then leave blank.
If this field is coded as 2 (No) or 9 (Unknown), and a second
colonoscopy is performed within the cycle to complete the removal
of polyps, See Item 9.2 “Final diagnosis” and Item 9.3 “Date of
diagnosis” for guidance on how to report histological findings.
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EXAMPLE:
If all polyps were completely removed: 1
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ITEM NO / NAME: 6.3.13: Recommended next follow-up procedure within this
cycle after 3rd test.
PURPOSE:
To indicate the next recommended procedure following the
completion of the third test.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
1 = Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to complete diagnosis*
8 = None (cycle is complete)
EXPLANATION:
Once the third test is completed, the next recommended procedure
to be completed within the screening cycle to rule out cancer, or
not, should be reported.
If the next recommended procedure for the client is surgery,
indicate 4 (Surgery). Items 8.1 and 8.2 should then be completed,
along with any final diagnosis and treatment data where applicable.
No further procedures (6.4.01) should be reported. Item 6.4.01 will
be completed with 0 (None).
If the next test recommended is a screening exam (FOBT or FIT),
indicate 8 (None). The new screening test will begin a new CCDE
record. Item 6.4.01 will be completed with 0 (None).
EXAMPLE:
If a DCBE is recommended as the next procedure within this clients
“cycle”: 3
REVISION HISTORY:
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ITEM NO / NAME: 6.4.01: 4th Test provided
PURPOSE:
To indicate the actual fourth test provided through the program.
For the purposes of this study “provided” = “paid for”.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
0 = None
3 = Sigmoidoscopy
4 = Colonoscopy
5 = Double-contrast barium enema (DCBE)
EXPLANATION:
Report the next test provided. Only funded colorectal diagnostic
tests should be reported in the CCDEs. If a non-funded test is
provided (e.g. an MRI), then that test should not be reported in the
CCDEs. If the non-funded test is the only additional test performed,
then this field should be completed as 0 (None).
This test should match the test reported in 6.3.13, however it is
understood that client compliance may dictate that they will not be
the same.
If a fourth test was not performed, indicate 0 (None), and leave
items 6.4.03 through 6.4.13 blank.
The fourth test may not be an FOBT or FIT. These exams are
considered screening tests, which would begin a new record.
EXAMPLE:
If the fourth test actually provided to the client is a sigmoidoscopy: 3
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ITEM NO / NAME: 6.4.02: Date of 4th test
PURPOSE:
To specify the date of the fourth test.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
This field should always be completed.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a value
from 01 to 12, DD is a value from 01 to 31, and YYYY is the year of
the procedure. If just the year is known, blank fill the month and
day. If just the year and month are known, blank fill the day (e.g.
08 2006). This field should not be left completely blank.
EXPLANATION:
This field should be completed if Item 6.4.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
EXAMPLE:
If a colonoscopy was performed on August 1, 2006: 08012006
REVISION HISTORY:
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ITEM NO / NAME: 6.4.03: Provider specialty
PURPOSE:
To report the specialty of the clinician providing the fourth test.
LENGTH:
2
TYPE:
Numeric, right justify.
SKIP PATTERN:
This field should be completed if Item 6.4.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = General practitioner
2 = Internist
3 = Family practitioner
4 = Gastroenterologist
5 = General surgeon
6 = Colorectal surgeon
7 = Licensed practical nurse
8 = Registered nurse
9 = Nurse practitioner
10 = Physician assistant
99 = Unknown
EXPLANATION:
This field should capture the medical practice specialty of the
provider who performed or provided the fourth test reported in Item
6.4.01.
EXAMPLE:
If the provider specialty for the fourth test is a general surgeon: 5
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ITEM NO / NAME: 6.4.04: Clinical practice site
PURPOSE:
To report the type of clinical practice for the provider reported in
6.4.03.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.4.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Doctor’s office
2 = Ambulatory endoscopy/surgery center
3 = Hospital
4 = Health clinic
9 = Unknown
EXPLANATION:
This field should report the type of clinical practice for the provider
reported in Item 6.4.03 (Provider specialty).
EXAMPLE:
If the provider’s practice is located in a hospital: 3
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ITEM NO / NAME: 6.4.06: Results of endoscopy or DCBE
PURPOSE:
To specify the results of a sigmoidoscopy, colonoscopy or DCBE, if
it was the fourth test performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.4.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Normal/negative/diverticulosis/hemorrhoids
2 = Other finding not suggestive of cancer/polyp(s)
3 = Polyp(s)/suspicious for cancer/presumed cancer
4 = No findings/inconclusive
5 = Pending
9 = Unknown
EXPLANATION:
If more than one result is noted on the medical chart, then report
the most severe.
Results from an incomplete or inconclusive test should always be
coded as 4 (No Findings/inconclusive), regardless if any specific
findings were noted. An incomplete test may be due to patient
discomfort or distress. Inconclusive findings may be due to
obstruction, inadequate preparation and retained fecal material,
physician fatigue or cecum not reached. Any specific findings that
were noted from an incomplete or inconclusive test should be
captured and reported elsewhere in the CCDE, including reporting
in Sections 6 “Screening and Diagnostic Tests Provided” and
Section 7 “Diagnosis Information for All Polyps/Lesions” on
polyps/lesions identified or removed. Another screening test should
be recommended following an incomplete or inconclusive test.
EXAMPLE:
If result of the DCBE was suspicious for cancer: 3
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ITEM NO / NAME: 6.4.07: Was the bowel preparation considered adequate by the
clinician performing the endoscopy or DCBE?
PURPOSE:
To indicate the adequacy of the bowel preparation for a
sigmoidoscopy, colonoscopy or DCBE, if it was the fourth test
performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.4.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE); otherwise leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
Adequacy of the bowel preparation will be determined by the
clinician performing the test. A response of 1 (Yes) can only be
reported if the procedure report explicitly states that the bowel
preparation was adequate, otherwise report 9 (Unknown).
If procedure report indicates adequate bowel preparation: 1
EXAMPLE:
REVISION HISTORY:
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ITEM NO / NAME: 6.4.08: Was the cecum reached during the colonoscopy?
PURPOSE:
To indicate whether or not the procedure notes report that the
cecum was reached during the colonoscopy, if it was the fourth
procedure performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.4.01 = 4 (Colonoscopy);
otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
If the 4th procedure performed was a colonoscopy, indication of
whether the cecum was reached during the procedure should be
reported.
The procedure report must explicitly state that the cecum was
reached during the colonoscopy in order to report 1 (Yes);
otherwise report 9 (Unknown).
EXAMPLE:
If cecum was not reached: 2
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ITEM NO / NAME: 6.4.09: Complications of endoscopy or DCBE.
PURPOSE:
To indicate whether there were complications due to the
sigmoidoscopy, colonoscopy or DCBE, if it was the fourth test
performed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.4.01 = 3 (Sigmoidoscopy),
4 (Colonoscopy) or 5 (DCBE), otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No/unknown
EXPLANATION:
If Item 6.4.01 = 3 (Sigmoidoscopy), 4 (Colonoscopy) or 5 (DCBE),
indicate whether or not complications occurred from the procedure
which required medical attention.
If complications = 1 (Yes), then the complication should be reported
on the Adverse Events Reporting form and submitted to the CDC
on a quarterly basis, as detailed in the Adverse Events Reporting
Form (Appendix E).
If the client is hospitalized because of an immediate complication,
please notify your consultation team at CDC with 72 hours of the
hospitalization by email. You should then send a completed
Adverse Events Report Form to the CDC within five (5) days.
Please see the Adverse Events Reporting Form (Appendix E) for
further guidance.
EXAMPLE:
If rectal bleeding occurred 3 days after a procedure: 1
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ITEM NO / NAME: 6.4.10: Was a biopsy/polypectomy performed during the
endoscopy?
PURPOSE:
To indicate if biopsy or polypectomy was performed during the
sigmoidoscopy or colonoscopy.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.4.01 is 3 (Sigmoidoscopy)
or 4 (Colonoscopy); otherwise, it should be blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
This field should only be completed if the fourth test provided is
either a colonoscopy or sigmoidoscopy.
EXAMPLE:
If a polypectomy was performed during a colonoscopy: 1
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ITEM NO / NAME: 6.4.11: Number of specimens sent to pathology (from
endoscopy)
PURPOSE:
To report the actual number of specimens removed during a biopsy
or polypectomy, and sent to pathology.
LENGTH:
2
TYPE:
Numeric – right justified
SKIP PATTERN:
This field should be completed if Item 6.4.01 was 3
(Sigmoidoscopy) or 4 (Colonoscopy) AND Item 6.4.10
(Biopsy/polypectomy performed) is 1 (Yes); otherwise, it should be
blank.
CONTENTS:
0 = Biopsy performed, no specimens sent
1 = One
2 = Two specimens
…
97 = Ninety-seven
98 = ≥ Ninety-eight
99 = Unknown
EXPLANATION:
The actual number of specimens sent to pathology should be
acquired and reported. If a biopsy/polypectomy was performed, but
no specimens were sent to pathology (e.g. specimen
contaminated), code 0 (Biopsy performed, no specimen sent).
When more than 98 specimens are collected during the
colonoscopy/sigmoidoscopy, report 98 (≥ 98 specimens).
If it is unknown whether any specimens were sent to pathology,
code 99 (Unknown). If the exact number of specimens sent to
pathology is unknown, code 99 (Unknown).
This field includes samples removed entirely or in part. If a single
polyp is removed piecemeal, report the number of specimens, not
the number of polyps.
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EXAMPLE:
If a biopsy was performed during a colonoscopy and 6 specimens
were sent to pathology: 6
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ITEM NO / NAME: 6.4.12: Completeness of polyp removal (from colonoscopy).
PURPOSE:
To indicate if polyps were completely removed during the fourth
test, if it was a colonoscopy. Do not complete this field if no polyps
were identified.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should be completed if Item 6.4.01 = 4 (Colonoscopy)
and Item 6.4.06 = 3 (Polyps/suspicious for cancer/presumed
cancer) and Item 7.0 ≠ 0 (No polyps/lesions).
This field should be completed if Item 6.4.01 = 4 (Colonoscopy)
and Item 6.4.06 = 4 (No findings/inconclusive) and Item 7.0 ≠ 0 (No
polyps/lesions).
Otherwise, leave blank.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
The intent of this field is to report if the colon was cleared of all
polyps noted during the colonoscopy. This field should only be
completed if the fourth test performed is a colonoscopy and polyps
were identified. Do not complete this field if no polyps were
identified.
If 6.4.06 = 3 and 7.0 ≠ 0; or
If 6.4.06 = 4 and 7.0 ≠ 0, then:
•
•
•
If all polyps noted during colonoscopy were removed, code 1
(Yes)
If all polyps noted were not removed, code 2 (No)
If no polyps were seen or suspected, code 9 (Unknown)
If 6.4.06 ≠ 3 or 4 then leave blank.
If this field is coded as 2 (No) or 9 (Unknown), and a second
colonoscopy is performed within the cycle to complete the removal
of polyps, See Item 9.2 “Final diagnosis” and Item 9.3 “Date of
diagnosis” for guidance on how to report histological findings.
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EXAMPLE:
If all polyps were completely removed: 1
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ITEM NO / NAME: 6.4.13: Recommended next follow-up procedure within this
cycle after 4th test.
PURPOSE:
To indicate the next recommended procedure following the
completion of the fourth test.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
4 = Surgery to complete diagnosis*
8 = None (cycle is complete)
EXPLANATION:
If the next recommended procedure for the client is surgery,
indicate 4 (Surgery). Items 8.1 and 8.2 should then be completed,
along with any final diagnosis and treatment data where applicable.
If the next test recommended is a screening exam (FOBT/FIT),
indicate 8 (None). The new screening test will begin a new CCDE
record.
EXAMPLE:
If no further diagnostic tests are recommended: 8
REVISION HISTORY:
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ITEM NO / NAME: 7.0: Total number of polyps/lesions
PURPOSE:
To indicate the total number of unique polyps/lesions identified
through all colonoscopies and/or sigmoidoscopies during the
client’s “cycle”. Do not report specimens from surgical resections.
LENGTH:
2
TYPE:
Numeric - right justify
SKIP PATTERN:
This field should always be completed.
CONTENTS:
0 = No polyps/lesions
1 = One polyp/lesion
2 = Two polyps/lesions
…
97 = ≥ Ninety-seven polyps/lesions
98 = At least one polyp/lesion, exact number not known
99 = Unknown
EXPLANATION:
The actual number of polyps or lesions should be acquired and
reported. If a colonoscopy or sigmoidoscopy was performed, but
no polyps or lesions were noted, code 0 (No polyps or lesions).
When more than 97 polyps or lesions are collected during the
colonoscopy/sigmoidoscopy, report 97 (≥ 97 polyps/lesions).
If the report indicates polyps or lesions were seen, but no definite
account of the number seen, indicate 98 (At least one polyp/lesion
seen, exact number not known).
If it is unknown whether any polyps or lesions were seen, code 99
(Unknown).
EXAMPLE:
If 8 polyps/lesions are noted: 8
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ITEM NO / NAME: 7.01.1: Location of 1st polyp/lesion*
PURPOSE:
To report the location of the polyp or lesion reported in the
endoscopy/pathology report.
*NOTE: This Item is repeated for polyps/lesions 1 through 15
(Items 7.02.1, 7.03.1, …, 7.15.1). For brevity, it will only be listed
once. Up to 15 responses (if needed) should use the values listed
here. For example: if Item 7.0 is reported as 5, you would only
complete the first 5 location fields. The rest should be left blank.
LENGTH:
2
TYPE:
Numeric - right justify
SKIP PATTERN:
If 7.0 “Total number of polyps/lesions” is reported as 1 through 98,
this field should be completed. Otherwise, leave blank.
CONTENTS:
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
EXPLANATION:
The location of the polyp/lesion is generally found on the
endoscopy report. The individual translating clinical data into the
CCDEs will need to carefully compare the endoscopy report and
the pathology report in order to “match up” the correct
polyps/lesions.
Programs should encourage their endoscopists to report the
anatomic location of each polyp, rather than distance in centimeters
from the anal verge. If the only information given is the distance,
indicate 99 (Unknown).
If the location for a lesion is not reported, indicate 99 (Unknown).
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EXAMPLE:
If a lesion was noted on the transverse colon: 6
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ITEM NO / NAME: 7.01.2: Size of 1st polyp/lesion*
PURPOSE:
To report the size of the polyp or lesion reported in the
endoscopy/pathology report.
*NOTE: This Item is repeated for polyps/lesions 1 through 15
(Items 7.02.2, 7.03.2, …, 7.15.2). For brevity, it will only be listed
once. Up to 15 responses (if needed) should use the values listed
here. For example: if Item 7.0 is reported as 5, you would only
complete the first 5 size fields. The rest should be left blank.
LENGTH:
2
TYPE:
Numeric – right justify
SKIP PATTERN:
If Item 7.0 “Total number of polyps/lesions” is 0 (No polyps), then
this field should be left blank.
CONTENTS:
0 = < 1 mm
1 = One mm
2 = Two mm
…
98 = ≥ 98 mm
99 = Unknown
EXPLANATION:
Report the diameter of the polyp lesion in millimeters (mm) or the
longest dimension of the polyp/lesion. This should be the size of
the actual polyp and not the size of the biopsy specimen submitted
for pathology.
The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and the pathology report in
order to “match up” the correct polyps.
Size may be found on both the endoscopy and pathology reports,
but size from the endoscopy report is preferred. If the specimen is
not intact when sent to the pathology lab, do not report specimen
size from the pathology report.
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EXAMPLE:
If the size of the lesion is 14 mm: 14
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ITEM NO / NAME: 7.01.3.1: Procedure for removal of 1st polyp/lesion (1)*
PURPOSE:
To report the procedure performed during the removal of the
polyp/lesion reported in 7.01.1.
*NOTE: This Item is repeated for polyps/lesions 1 through 15
(Items 7.02.3.1, 7.03.3.1, …, 7.15.3.1). For brevity, it will only be
listed once. Up to 15 responses (if needed) should use the values
listed here. For example: if Item 7.0 is reported as 5, you would
only complete the first 5 sets of procedure fields. The rest should
be left blank.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 7.0 “Total number of polyps/lesions” is 0 (No polyps), then
this field should be left blank.
CONTENTS:
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
EXPLANATION:
For each polyp/lesion reported in 7.01 through 7.15, up to three (3)
procedures may be reported. There is no specification as to the
order in which the procedures are reported.
If the polyp/lesion identified on the endoscopy report was not
biopsied or removed, code 7 (Not biopsied or removed) in Item
7.01.3.1; Items 7.01.3.2 and 7.01.3.3 should be left blank.
EXAMPLE:
If a cold biopsy was performed: 3
REVISION HISTORY:
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ITEM NO / NAME: 7.01.3.2: Procedure for removal of 1st polyp/lesion (2)*
PURPOSE:
To report a second procedure performed during the removal of the
polyp/lesion reported in 7.01.1.
*NOTE: This Item is repeated for polyps/lesions 1 through 15
(Items 7.02.3.2, 7.03.3.2, …, 7.15.3.2). For brevity, it will only be
listed once. Up to 15 responses (if needed) should use the values
listed here. For example: if Item 7.0 is reported as 5, you would
only complete the first 5 sets of procedure fields. The rest should
be left blank.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 7.0 “Total number of polyps/lesions” is 0 (No polyps), then
this field should be left blank. If Item 7.01.3.1 “Procedure for
removal of the 1st polyp/lesion (1)” is reported as 7 (Not biopsied or
removed), then this field should be left blank.
CONTENTS:
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
EXPLANATION:
For each polyp/lesion reported in 7.01 through 7.15, up to three (3)
procedures may be reported. There is no specification as to the
order in which the procedures are reported.
If more than one procedure was performed during the removal of
the polyp/lesion reported in 7.01.1, then report the second
procedure here.
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EXAMPLE:
If a cold biopsy was performed: 3
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ITEM NO / NAME: 7.01.3.3: Procedure for removal of 1st polyp/lesion (3)*
PURPOSE:
To report a third procedure performed during the removal of the
polyp/lesion reported in 7.01.1.
*NOTE: This Item is repeated for polyps/lesions 1 through 15
(Items 7.02.3.3, 7.03.3.3, …, 7.15.3.3). For brevity, it will only be
listed once. Up to 15 responses (if needed) should use the values
listed here. For example: if Item 7.0 is reported as 5, you would
only complete the first 5 sets of procedure fields. The rest should
be left blank.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 7.0 “Total number of polyps/lesions” is 0 (No polyps), then
this field should be left blank. If Item 7.01.3.1 “Procedure for
removal of 1st polyp/lesion (1)” is reported as 7 (Not biopsied or
removed), then this field should be left blank.
CONTENTS:
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
EXPLANATION:
For each polyp/lesion reported in 7.01 through 7.15, up to three (3)
procedures may be reported. There is no specification as to the
order in which the procedures are reported.
If more than two procedures were performed during the removal of
the polyp/lesion reported in 7.01.1, then report the third procedure
here.
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EXAMPLE:
If a cold biopsy was performed: 3
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ITEM NO / NAME: 7.01.4: Was 1st polyp/lesion completely removed?*
PURPOSE:
Indicate whether the polyp/lesion reported in 7.01.1 was completely
removed.
*NOTE: This Item is repeated for polyps/lesions 1 through 15
(Items 7.02.4, 7.03.4, …, 7.15.4). For brevity, it will only be listed
once. Up to 15 responses (if needed) should use the values listed
here. For example: if Item 7.0 is reported as 5, you would only
complete the first 5 “removed” fields. The rest should be left blank.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 7.0 “Total number of polyps/lesions” is 0 (No polyps/lesions),
or Item 7.01.3.1 “Procedure for removal of 1st polyp/lesion (1)” is 7
(Not biopsied or removed), then this field should be left blank;
otherwise this item should be completed.
CONTENTS:
1 = Yes
2 = No
9 = Unknown
EXPLANATION:
For each polyp/lesion reported in 7.01 through 7.15, indicate if that
polyp/lesion was completely removed.
EXAMPLE:
If the polyp/lesion was completely removed: 1
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ITEM NO / NAME: 7.01.5: Histology of 1st polyp/lesion*
PURPOSE:
Report the histology of the polyp/lesion reported in 7.01.1.
*NOTE: This Item is repeated for polyps/lesions 1 through 15
(Items 7.02.5, 7.03.5, …, 7.15.5). For brevity, it will only be listed
once. Up to 15 responses (if needed) should use the values listed
here. For example: if Item 7.0 is reported as 5, you would only
complete the first 5 histology fields. The rest should be left blank.
LENGTH:
2
TYPE:
Numeric - right justify
SKIP PATTERN:
If Item 7.0 “Total number of polyps/lesions” is 0 (No polyps/lesions),
or Item 7.01.3.1 “Procedure for removal of 1st polyp/lesion (1)” is 7
(Not biopsied or removed), then this field should be left blank;
otherwise this item should be completed.
CONTENTS:
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia
noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ
carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
EXPLANATION:
For each polyp/lesion reported in 7.01 through 7.15, indicate the
histology for each polyp/lesion that was removed. All histologies
should be reviewed and a final diagnosis recorded in Item 9.2 “Final
Diagnosis”.
If the polyp/lesion was submitted to pathology as a piecemeal
fragments and more than one histological diagnosis was reported,
report the worst. The response options are listed in general order
of severity.
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EXAMPLE:
If the histology for the polyp/lesion removed is carcinoma: 11
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The following table was designed to assist programs in mapping specific ICD-O
morphology codes to the CCDE Histology categories.
CCDE Colorectal Histology Categories
International Classification of Disease for
Oncology, 3rd Edition, Acceptable Morphology
Codes and Terminology from Common Codes
1=Normal or other non-polyp histology
n/a
2=Non-adenomatous polyp (inflammatory,
hamartomatous, etc.)
3=Hyperplastic polyp
4=Adenoma, NOS (no high-grade dysplasia
noted)
5=Adenoma, tubular (no high-grade dysplasia
noted)
n/a
n/a
8140-8147, 8160-8162, 8180-8210, 8212, 82148221, 8250-8260, 8262, 8264-8506, 8520-8550,
8560, 8570-8573, 8940-8941 (with behavior codes
of /0)
8140/0 Adenoma, NOS
8210/0 Adenomatous polyp, NOS
8212/0 Flat adenoma
8220/0 Adenomatous polyposis coli
8221/0 Multiple adenomatous polyps
8211 (with behavior code of /0)
8211/0
6=Adenoma, mixed tubular villous (no highgrade dysplasia noted)
8263 (with behavior code of /0)
8263/0
7=Adenoma, villous (no high-grade dysplasia
noted)
9=Adenoma with high-grade dysplasia
(includes in situ carcinoma)
10=Adenocarcinoma, invasive
128
Tubulovillous adenoma, NOS
8261 (with behavior code of /0)
8261/0
8=Adenoma, serrated (no high-grade
dysplasia noted)
Tubular adenoma, NOS
Villous adenoma, NOS
8213 (with behavior code of /0)
8213/0 Serrated adenoma
8140-8147, 8160-8162, 8180-8221, 8250-8506,
8520-8550, 8560, 8570-8573, 8940-8941 (with
behavior codes of /2)
8140/2 Adenocarcinoma in situ, NOS
Adenocarcinoma in situ in
8210/2 adenomatous polyp
Adenocarcinoma in situ in villous
8261/2 adenoma
Adenocarcinoma in situ in
8263/2 tubulovillous adenoma
8140-8147, 8160-8162, 8180-8221, 8250-8506,
8510, 8520-8550, 8560, 8570-8573, 8940-8941
(with behavior codes of /3)
8140/3 Adenocarcinoma, NOS
8141/3 Scirrhous adenocarcinoma
8210/3 Adenocarcinoma in adenomatous
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Section 7 - Diagnosis Information for All Polyps/Lesions
10=Adenocarcinoma, invasive (continued)
11=Carcinoma, other
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8211/3
8214/3
8220/3
Tubular adenocarcinoma
Parietal cell carcinoma
Adenocarcinoma in adenomatous
polyposis coli
8221/3 Adenocarcinoma in multiple
adenomatous polyps
8260/3 Papillary adenocarcinoma, NOS
8261/3 Adenocarcinoma in villous adenoma
8262/3 Villous adenocarcinoma
8263/3 Adenocarcinoma in tubulovillous
adenoma
8470/3 Mucinous cystadenocarcinoma, NOS
8480/3 Mucinous adenocarcinoma
8481/3 Mucin-producing adenocarcinoma
8490/3 Signet ring cell carcinoma
8560/3 Adenosquamous carcinoma
8570/3 Adenocarcinoma with squamous
metaplasia
8571/3 Adenocarcinoma with cartilaginous
and osseous metaplasia
8940/3 Mixed tumor, malignant, NOS
8941/3 Carcinoma in pleomorphic adenoma
8000-8139, 8148-8159, 8163-8179, 8222-8249,
8507-8509, 8511-8519, 8551-8559, 8561-8569,
8574-8939, 8942-9989 (with behavior codes of /3)
8001/3 Tumor cells, malignant
8002/3 Malignant tumor, small cell type
8004/3 Malignant tumor, spindle cell type
8005/3 Malignant tumor, clear cell type
8050/3 Papillary carcinoma, NOS
8070/3 Squamous cell carcinoma, NOS.
8240/3 Carcinoid tumor, NOS
8249/3 Atypical carcinoid tumor
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Section 8 - Diagnosis Information for Surgeries Performed to Complete Diagnosis
ITEM NO / NAME: 8.1: Histology from surgical resection
PURPOSE:
Report the worst histopathological diagnosis made from the
surgical resection reported in 6.x.13 (where x is either the 1st, 2nd,
3rd or 4th test reported in section 6) if the client underwent surgery.
LENGTH:
2
TYPE:
Numeric - right justify
SKIP PATTERN:
If Item 6.x.13 is 4 (Surgery to complete diagnosis), then this field
should be completed; otherwise, leave blank.
CONTENTS:
0 = Surgery recommended but not performed
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia
noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ
carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
NOTE: For guidance on converting ICD-O morphology to CCDE
histology from surgical resection, refer to table following
Item 7.01.5 “Histology of 1st polyp/lesion”.
EXPLANATION:
Most often, if a polyp is detected on colonoscopy, it can be
removed during the colonoscopy and the client will not need
surgery. On some occasions, if the polyp is large or the lesion is
suspicious for cancer, a biopsy will be taken, but the lesion will not
be removed in entirety during the colonoscopy, but instead will be
removed during a subsequent surgery.
This is the worst histopathological diagnosis made from surgical
resection. The response options are listed in general order of
severity. If more than one surgery was performed in order to obtain
a final diagnosis (Item 9.2), report the worst histopathological
diagnosis made from the surgical resection which provided the final
diagnosis.
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Section 8 - Diagnosis Information for Surgeries Performed to Complete Diagnosis
If surgery was recommended in 6.x.13 “Recommended next followup procedure…”, but was not completed, code 0 (Surgery
recommended but not performed). If no surgery was
recommended in these fields, then Item 8.1 should be left blank.
If the histology from surgical resection is not found in the pathology
report, indicate 99 (Unknown).
Use the histology from surgical resection in conjunction with all of
the polyp/lesion histologies in Item 9.2 “Final Diagnosis”.
EXAMPLE:
If the histology for the polyp/lesion removed is carcinoma: 11
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Section 8 - Diagnosis Information for Surgeries Performed to Complete Diagnosis
ITEM NO / NAME: 8.2: Date surgery performed
PURPOSE:
Indicate the date of the surgical resection.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
If Item 6.x.13 is 4 (Surgery to complete diagnosis), then this field
should be completed; otherwise, leave blank.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a value
from 01 to 12, DD is a value from 01 to 31, and YYYY is the year of
the procedure. If just the year is known, blank fill the month and
day. If just the year and month are known, blank fill the day (e.g.
08 2006). This field should not be left completely blank.
EXPLANATION:
This field captures the date that the surgery to complete diagnosis
was performed. If more than one surgical resection was performed
to obtain a final diagnosis, report the date of the surgery which
provided the final diagnosis (Item 9.2).
Frequently, the screening cycle will conclude with colonoscopy and
surgery will not be required to complete the diagnosis. Surgery will
only be performed if the suspicious lesion could not be completely
removed during colonoscopy.
If Item 8.1 was 0 (Surgery recommended but not performed), then
this field should be left blank.
EXAMPLE:
If a surgery was performed on August 1, 2006: 08012006
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Section 9 - Final Diagnosis
ITEM NO / NAME: 9.1: Status of diagnosis
PURPOSE:
To specify the status of final diagnosis.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed
CONTENTS:
1 = Complete (final diagnosis made)
2 = Pending final diagnosis
3 = Verbal/written refusal for any test needed to obtain a final
diagnosis
4 = Client moved before final diagnosis was made
5 = Client died before final diagnosis was made
6 = Lost to follow-up
9 = Unknown
EXPLANATION:
After all screening and diagnostic tests were performed/offered to
the client, report the status of the client’s care.
If a client receives a single screening test, which is
normal/negative, then complete this field as 1 (Complete).
If a client’s tests have not yet been completed, and no final
diagnosis has been determined, but it is time to submit data to the
CDC, the status of diagnosis should be reported as 2 (Pending).
These records should be monitored so that as the client’s tests are
completed, and a final diagnosis is made, this field should be
updated to the appropriate status of diagnosis.
If the client severs his or her relationship with the program and
receives further screening or diagnostic tests outside of the
program report the status of diagnosis as 3 (Refused).
All programs must have a policy in place to define how much time
can elapse before the client is deemed 3 (Refused) or 6 (Lost to
follow-up).
If the only test provided to the client was an FOBT/FIT kit, and it
was not returned, report the status of diagnosis as 9 (Unknown).
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Section 9 - Final Diagnosis
EXAMPLE:
If status of client’s care for the current CCDE record is complete: 1
REVISION HISTORY:
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Section 9 - Final Diagnosis
ITEM NO / NAME: 9.2: Final diagnosis
PURPOSE:
To specify the final diagnosis after all procedures have been
completed.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 9.1 “Status of final diagnosis” is 1 (Complete), then this field
should be completed; otherwise, leave blank.
CONTENTS:
1 = Normal/negative
2 = Polyp, no high grade dysplasia2
3 = Polyp with high grade dysplasia1, 2
4 = Cancer1, 2
EXPLANATION:
After all screening and diagnostic tests were performed/offered to
the client, report the final diagnosis that will determine the rescreening or surveillance test recommendation. In some cases,
polyps may be removed during differing procedures, with each
procedure having a different polyp histology. Please report the
worst diagnosis (among all procedures) as the final diagnosis.
If the only test performed in the screening cycle (Items 6.1.01) was
an FOBT or FIT that was negative, then complete this field as 1
(Normal/negative).
1
Section 10 Diagnosis Information for Cancer/High Grade
Dysplasia, must be completed if Item 9.2 “Final Diagnosis” is 3
(Polyp with high grade dysplasia) or 4 (Cancer).
2
Section 11 Treatment Information, must be completed if Item 9.2
“Final Diagnosis” is 2 (Polyp, no high grade dysplasia), 3 (Polyp
with high grade dysplasia) or 4 (Cancer).
EXAMPLE:
If the final diagnosis is Normal: 1
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Section 9 - Final Diagnosis
ITEM NO / NAME: 9.3: Date of diagnosis
PURPOSE:
To specify the date of final diagnosis.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
This field should be completed if Item 9.1 “Status of Diagnosis” is 1
(Complete), 3 (Refused), 4 (Moved), 5 (Died) or 6 (Lost); otherwise,
it should be blank.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a value
from 01 to 12, DD is a value from 01 to 31, and YYYY is the year of
the biopsy. If any part of the date is unknown, blank-fill only that
part. For example, if the month and year of diagnosis are known,
but the day is not, then blank-fill the day (e.g. 08 2006).
EXPLANATION:
This field should indicate the date of the final pathology report or
the date of the “normal” screening test. If more than one procedure
was performed to obtain a final diagnosis, report the date of the
procedure which was the first occurrence of a diagnosis of cancer
(or worst histology) as the date of final diagnosis.
If the client refused, or was determined to be lost to follow-up or
deceased, an administrative close-out date should be reported
here. If client moved before all tests were completed and a final
diagnosis obtained, an administrative close-out date should be
used as the date of diagnosis.
EXAMPLE:
If the date of the final pathology report is July 15, 2006: 07152006
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Section 9 - Final Diagnosis
ITEM NO / NAME: 9.4: Recommended screening or surveillance test for next
cycle
PURPOSE:
To indicate the next recommended procedure to the client at the
end of the “cycle”.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 9.1 “Status of diagnosis” is 1 (Complete), this field should
always be completed; otherwise leave blank.
CONTENTS:
1 = Take-home FOBT
2 = Take-home FIT
3 = Sigmoidoscopy
4 = Colonoscopy
5 = DCBE
6 = None
9 = Unknown
EXPLANATION:
Report the next screening or surveillance test recommended to the
client at the end of the cycle. This can be a surveillance
colonoscopy following a previous abnormal colonoscopy and/or
surgery, or the next screening test recommended to the client
following a normal/negative test.
If client is terminally ill, or for other reasons no further tests are
recommended, then code this as 6 (None).
EXAMPLE:
If a FOBT is recommended as the next screening procedure: 1
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Section 9 - Final Diagnosis
ITEM NO / NAME: 9.5: Indication for screening or surveillance test for next cycle
PURPOSE:
To indicate the next recommended test made to the client.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 9.1 “Status of diagnosis” is 1 (Complete), this field should
always be completed; otherwise leave blank.
If Item 9.4 “Recommended screening or surveillance test for next
cycle” is 6 (None) or 9 (Unknown), leave blank.
CONTENTS:
1 = Screening
2 = Surveillance after a positive colonoscopy and/or surgery
EXPLANATION:
If a test was recommended in Item 9.4, then the indication for this
test (screening vs. surveillance) should be reported.
Programs should encourage their providers to make re-screening
and surveillance frequency recommendations based on published
guidelines, when available.
EXAMPLE:
If the next recommended test is a screening test: 1
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Section 9 - Final Diagnosis
ITEM NO / NAME: 9.6: Number of months before screening or surveillance test
for next cycle.
PURPOSE:
To indicate the recommended interval between Item 9.3 “Date of
final diagnosis” and next recommended screening/surveillance test.
LENGTH:
3
TYPE:
Numeric - right justify
SKIP PATTERN:
If Item 9.1 “Status of diagnosis” is 1 (Complete) AND Item 9.4
“Recommended screening or surveillance test for next cycle” has a
reported value of 1 – 5, then this field should be completed;
otherwise leave blank.
CONTENTS:
12 = Twelve months
13 = Thirteen months
…
180 = One hundred eighty months
999 = Unknown
EXPLANATION:
If a test was recommended in Item 9.4, then the report the interval
between the final diagnosis and the next test date. If Item 9.4 is
reported as 6 (None) or 9 (Unknown), this field should be left blank.
EXAMPLE:
If the recommended interval before the next test is two years: 24
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directions: Leave blank if 9.1≠ 1
Chapter 2 – CCDE Field Descriptions
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.1: Stage at diagnosis/treatment
PURPOSE:
To report the stage for a final diagnosis of 3 (High grade dysplasia)
or 4 (Cancer), as reported in Item 9.2.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should only be completed if Item 9.2 “Final Diagnosis” is 3
(High grade dysplasia) or 4 (Cancer); otherwise, leave blank.
CONTENTS:
0 = Stage 0 (high grade dysplasia, severe dysplasia, or in situ)
1 = Stage I
2 = Stage II
3 = Stage III
4 = Stage IV
9 = Unknown/unstaged
EXPLANATION:
If Item 9.2 “Final Diagnosis” indicates 3 (Polyp with High grade
dysplasia) or 4 (Cancer) was found, then the AJCC cancer stage
used as a basis for clinical decisions should be reported. This can
be based on clinical and/or pathological information.
EXAMPLE:
If the Stage at Diagnosis for cancer 1 is Stage II: 2
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.2: Recurrent cancers
PURPOSE:
Indicate if the cancer reported in Item 9.2 “Final Diagnosis” is a new
primary or a recurrent cancer.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 9.2 “Final Diagnosis” is 4 (Cancer), then this field should be
completed; otherwise, leave blank.
CONTENTS:
1 = New CRC primary
2 = Recurrent CRC
3 = Non-CRC primary (metastasis from another organ)
9 = Unknown
EXPLANATION:
If the cancer reported in Item 9.2 is a new colorectal primary
cancer, report 1 (New CRC primary). If the cancer is a metastasis
of a non-colorectal primary, then report as 3 (Non-CRC primary).
EXAMPLE:
If the cancer found is a recurrent CRC cancer: 2
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.3: Registry linkage status
PURPOSE:
Indicate if the diagnosis for this client reported in Item 9.2 “Final
Diagnosis” has been linked to the state cancer registry.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should only be completed if Item 9.2 “Final Diagnosis”
was reported as 3 (High grade dysplasia) or 4 (Cancer); otherwise
leave blank.
NOTE: The skip pattern for this field may be modified once a
finalized Registry linkage protocol has been developed.
CONTENTS:
1 = Pending linkage
2 = Linked, matched
3 = Linked, not matched
EXPLANATION:
A final diagnosis of high grade dysplasia or cancer should be linked
with the program’s state cancer registry. At the time of each CCDE
submission, this field should be updated to indicate if the record
has been linked or not.
If during the linkage process a client identified as having high-grade
dysplasia or cancer in the CCDEs is NOT identified in the state
cancer registry (based on matching algorithm guidelines being
developed by CDC using a combination of client identifiers such as
name and date of birth), indicate 3 (Linked, not matched).
EXAMPLE:
If the case is matched with a record in the state cancer registry: 2
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.4: Registry primary site
PURPOSE:
Report the primary site obtained from the cancer registry.
LENGTH:
4
TYPE:
Alphanumeric - left justify
SKIP PATTERN:
If Item 9.2 “Final Diagnosis” is reported as 3 (High grade dysplasia)
or 4 (Cancer), and Item 10.3 “Registry linkage status” is reported as
2 (Linked, matched), then this field should be completed; otherwise
leave blank.
NOTE: The skip pattern for this field may be modified once a
finalized Registry linkage protocol has been developed.
CONTENTS:
C000 through C999. The “C” must be included as part of the
variable response.
Chapter 4 (Registry Linkage) of this Data User’s Manual contains
documentation which provides a table of available primary site
codes as listed in the topography section of the International
Classification of Diseases for Oncology, Third Edition (ICD-O-3).
EXPLANATION:
If Item 10.3 “Registry linkage status” is reported as 2 (Linked and
matched), the primary site [NAACCR data item #400] obtained from
the cancer registry should be reported.
EXAMPLE:
If the primary site is cecum: C180
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.5: Registry CS-derived SS2000
PURPOSE:
To report the derived summary stage obtained from the cancer
registry.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 9.2 “Final Diagnosis” is reported as 3 (High grade dysplasia)
or 4 (Cancer), and Item 10.3 “Registry linkage status” is reported as
2 (Linked, matched), then this field should be completed; otherwise
leave blank.
NOTE: The skip pattern for this field may be modified once a
finalized Registry linkage protocol has been developed.
CONTENTS:
0 = In situ
1 = Localized
2 = Regional, direct extension only
3 = Regional, regional lymph nodes only
4 = Regional, extension and nodes
5 = Regional, NOS
7 = Distant
8 = Not applicable
9 = Unknown/unstaged
EXPLANATION:
If Item 10.3 “Registry linkage status” is reported as 2 (Linked,
matched), then report the collaborative stage (CS)-derived
summary stage 2001 [NAACCR data item #3020] obtained from the
cancer registry database. Please refer to the Web site
www.cancerstaging.org/cstage/csmanualpart1.pdf for general
instructions provided to cancer registry sites on reporting this
information.
Chapter 4 (Registry Linkage) of this Data User’s Manual has
additional information for this item.
EXAMPLE:
If the registry CS-derived stage is localized: 1
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.6: Registry CS-derived AJCC stage group
PURPOSE:
To report the CS-derived AJCC stage group as indicated by the
cancer registry.
LENGTH:
2
TYPE:
Numeric
SKIP PATTERN:
If Item 9.2 “Final Diagnosis” is reported as 3 (High grade dysplasia)
or 4 (Cancer), and Item 10.3 “Registry linkage status” is reported as
2 (Linked, matched), then this field should be completed; otherwise
leave blank.
NOTE: The skip pattern for this field may be modified once a
finalized Registry linkage protocol has been developed.
CONTENTS:
Valid values for CS-derived AJCC stage include: 00-02, 10-24, 3043, 50-63, 70-74, 88, 90, 99.
NOTE: See Chapter 4 (Registry Linkage) of this Data User’s
Manual for a complete list of all available codes and their definitions
as reported in the Collaborative Staging Manual Coding
Instructions.
EXPLANATION:
If Item 10.3 “Registry linkage status” is reported as 2 (Linked,
matched), then report the collaborative stage (CS)-derived AJCC
stage [NAACCR data item #3000] obtained from the cancer registry
database.
EXAMPLE:
If polyp was diagnosed as a Stage II: 30
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.7: Registry CS extension
PURPOSE:
Indicate the extension of disease, as reported by the cancer
registry.
LENGTH:
2
TYPE:
Numeric
SKIP PATTERN:
If Item 9.2 “Final Diagnosis” is reported as 3 (High grade dysplasia)
or 4 (Cancer), and Item 10.3 “Registry linkage status” is reported as
2 (Linked, matched), then this field should be completed; otherwise
leave blank.
NOTE: The skip pattern for this field may be modified once a
finalized Registry linkage protocol has been developed.
CONTENTS:
Valid values for CS extension include: 00, 05, 10-16, 20, 30, 40, 42,
45, 46, 50, 55, 57, 60, 65, 66, 70, 75, 80, 95, 99.
NOTE: See Chapter 4 (Registry Linkage) of this Data User’s
Manual for a complete list of all available codes and their definitions
as reported in the Collaborative Staging Manual Coding
Instructions.
EXPLANATION:
If Item 10.3 “Registry linkage status” is reported as 2 (Linked,
matched), then report the collaborative stage (CS)-derived
extension [NAACCR data item #2810] obtained from the cancer
registry database.
EXAMPLE:
If the CS reported extension for Colon is “Localized, NOS”: 30
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.8: Registry CS lymph nodes
PURPOSE:
Indicate the lymph node involvement, as reported by the cancer
registry.
LENGTH:
2
TYPE:
Numeric
SKIP PATTERN:
If Item 9.2 “Final Diagnosis” is reported as 3 (High grade dysplasia)
or 4 (Cancer), and Item 10.3 “Registry linkage status” is reported as
2 (Linked, matched), then this field should be completed; otherwise
leave blank.
NOTE: The skip pattern for this field may be modified once a
finalized Registry linkage protocol has been developed.
CONTENTS:
Valid values for CS lymph nodes are 00, 10, 20, 30, 80, and 99.
NOTE: See Chapter 4 (Registry Linkage) of this Data User’s
Manual for a complete list of all available codes and their definitions
as reported in the Collaborative Staging Manual Coding
Instructions.
EXPLANATION:
If Item 10.3 “Registry linkage status” is reported as 2 (Linked,
matched), then report the collaborative stage (CS) lymph node
involvement [NAACCR data item #2830] obtained from the cancer
registry database.
EXAMPLE:
If the primary site is colon, and the lymph nodes involvement
reported is “Regional lymph node(s) for ascending colon: 20
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Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
ITEM NO / NAME: 10.9: Registry CS mets at diagnosis
PURPOSE:
Indicate any distant metastases at the time of diagnosis, as
reported by the cancer registry.
LENGTH:
2
TYPE:
Numeric
SKIP PATTERN:
If Item 9.2 “Final Diagnosis” is reported as 3 (High grade dysplasia)
or 4 (Cancer), and Item 10.3 “Registry linkage status” is reported as
2 (Linked, matched), then this field should be completed; otherwise
leave blank.
NOTE: The skip pattern for this field may be modified once a
finalized Registry linkage protocol has been developed.
CONTENTS:
00 = No; none
08 = Superior mesenteric lymph node(s)
10 = Distant lymph node(s)
11 = Rectosigmoid
Intermal iliac (hypogastric)
Obturator
12 = Other distant lymph node(s), including external iliac or
common iliac
40 = Distant metastases except code 10-12
Distant metastasis, NOS
Carcinomatosis
50 = (40) + (10); or (40) + any of [(10) to (12)]
99 = Unknown; distant metastasis cannot be assessed; not stated
in patient record
NOTE: See Chapter 4 (Registry Linkage) of this Data User’s
Manual for a complete list of all available codes and their definitions
as reported in the Collaborative Staging Manual Coding
Instructions.
EXPLANATION:
148
If Item 10.3 “Registry linkage status” is reported as 2 (Linked,
matched), then report the CS mets at diagnosis [NAACCR data
item #2850] obtained from the cancer registry database.
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 10 - Diagnosis Information for Cancer/High Grade Dysplasia
EXAMPLE:
If the mets at diagnosis are reported as “None”: 00
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
149
Section 11 - Treatment Information
ITEM NO / NAME: 11.1: Status of treatment
PURPOSE:
To specify the status of standard treatment for cancer.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
If Item 9.2 “Final Diagnosis” is reported as 2 (Polyp, no high grade
dysplasia), 3 (High grade dysplasia) or 4 (Cancer), then this field
should be completed; otherwise leave blank.
CONTENTS:
1 = Treatment started and/or completed
2 = Treatment pending
3 = Treatment not indicated
4 = Verbal/written refusal of treatment*
5 = Client moved
6 = Deceased
7 = Lost to follow-up*
9 = Unknown
EXPLANATION:
For the purpose of this demonstration program, the CDC requires
the reporting of standard or conventional treatments. Non-standard
or alternative treatments should not be reported as 1 (Treatment
Started). In the event that the client chooses a form of nonstandard or alternative treatment instead of standard treatment, this
field should be coded as 4 (Verbal/written refusal).
NOTE: Experimental drugs, such as those used in clinical trials,
may be reported as 1 (Treatment started).
The fact that a client is referred for standard treatment is NOT
sufficient confirmation that treatment has been started. A client
should be classified as having started treatment when the program
has confirmed that a plan for standard treatment has been
developed and actually started. The date when standard treatment
began refers to the client’s actual start of therapy.
A colonoscopy can often achieve screening and treatment
simultaneously, by detecting and removing a polyp. A complete
polypectomy would be considered both diagnostic and the only
required treatment. In this case, the procedure should be reported
in the Screening and Diagnostic Tests Provided section (6.x.01),
Treatment would be 1 (Started), and Item 11.2 “Date of Treatment”
will be the day of the procedure. In this instance, Item 9.3 “Date of
Diagnosis” and Item 11.2 “Date of Treatment” would be the same.
150
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 11 - Treatment Information
In the circumstance that surgical removal of a polyp or cancer is
complete, with no evidence of spread, surgery would also be
considered both diagnostic and the only required treatment. In this
case, the date of surgery should be reported in the Diagnosis
Information for Surgeries Performed section (Item 8.2), Treatment
would be 1 (Started), and Item 11.2 “Date of Treatment” will be the
day of the surgery.
If any additional treatment beyond a polypectomy or surgery is
required because of local or distant spread of a cancer (e.g.
chemotherapy or radiation therapy), the “Status of Treatment” and
“Date of Treatment” need to be determined by the start of the
standard or conventional treatment beyond that of the polypectomy
or surgery.
*Each program must have a policy in place to define how much
time can elapse before the client is deemed 4 (Refused) or 7 (Lost
to follow-up).
EXAMPLE:
If client refused treatment: 4
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
04/26/2006
Revised to indicate that categories 3 – 7
should have an administrative close-out
date reported in Item 11.2 (Date of
Treatment)
1.01
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
151
Section 11 - Treatment Information
ITEM NO / NAME: 11.2: Date of treatment
PURPOSE:
To report the date treatment began.
LENGTH:
8
TYPE:
Date
SKIP PATTERN:
If Item 11.1 “Status of treatment” is 2 (Pending) or 9 (Unknown),
this field may be blank; otherwise it must be completed.
CONTENTS:
An 8-digit date field of the form MMDDYYYY, where MM is a value
from 01 to 12, DD is a value from 01 to 31, and YYYY is the year of
the biopsy. If any part of the date is unknown, blank-fill only that
part. For example, if the month and year of diagnosis are known,
but the day is not, then blank-fill the day (e.g. 08 2006).
EXPLANATION:
If Item 11.1 “Status of Treatment” is 1 (Started), then complete with
the date the treatment began.
The fact that a client is referred for standard treatment is NOT
sufficient confirmation that treatment has been started. A client
should be classified as having started treatment when the program
has confirmed that a plan for standard treatment has been
developed and actually started. The date when standard treatment
began refers to the client’s actual start of therapy.
A colonoscopy can often achieve screening and treatment
simultaneously, by detecting and removing a polyp. A complete
polypectomy would be considered both diagnostic and the only
required treatment. In this case, the procedure should be reported
in the Screening and Diagnostic Tests Provided section (6.x.01),
Treatment would be 1 (Started), and Item 11.2 “Date of Treatment”
will be the day of the procedure. In this instance, Item 9.3 “Date of
Diagnosis” and Item 11.2 “Date of Treatment” would be the same.
Surgery may also be considered both diagnostic and the only
required treatment. In this case, the date of surgery should be
reported in the Diagnosis Information for Surgeries Performed
section (Item 8.2), Item 11.1 “Status of Treatment” would be 1
(Started), and “Date of Treatment” will be the day of the surgery.
If any additional treatment beyond a polypectomy or surgery is
required, the “Status of Treatment” and “Date of Treatment” need to
be determined by the start of the standard or conventional
treatment beyond that of the polypectomy or surgery.
152
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 11 - Treatment Information
Each program must have a policy in place to define how much time
can elapse before the client is deemed to be “Refused” or “Lost to
follow-up”
EXAMPLE:
Client began chemotherapy on December 15, 2006: 12152006
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
153
Section 11 - Treatment Information
ITEM NO / NAME: 11.3: Who paid for treatment
PURPOSE:
To report primary funding source for the treatment.
LENGTH:
1
TYPE:
Numeric
SKIP PATTERN:
This field should only be completed if Item 11.1 is 1 (Treatment
Started); otherwise, leave blank.
CONTENTS:
1 = Medicaid
2 = Other, state
3 = Medicare
4 = Self-pay (by client)
5 = Charity care/uncompensated
6 = Other
9 = Unknown
EXPLANATION:
If Item 11.1 “Status of Treatment” indicates that treatment was
started, then the primary funding source for the treatment should be
reported.
If funding for treatment comes from multiple sources, report the
most significant contributor to the funding cost.
A colonoscopy can often achieve screening and treatment
simultaneously, by detecting and removing a polyp. A complete
polypectomy would be considered both diagnostic and the only
required treatment. In this case, the funding source would be the
CDC which should be reported as 6 (Other).
Surgery may also be considered both diagnostic and the only
required treatment, which is funded by CDC. In these cases,
indicate 6 (Other).
EXAMPLE:
Medicare funds are used to cover treatment: 3
REVISION HISTORY:
154
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
Section 12 – Record Information
ITEM NO / NAME: 12.1: CCDE version
PURPOSE:
To report the CCDE version that the current record was collected
in.
LENGTH:
3
TYPE:
Numeric
SKIP PATTERN:
This field should always be completed.
CONTENTS:
100 = All data currently being collected/reported.
EXPLANATION:
As the demonstration program begins to evaluate data collected,
some variables may be dropped, new variables may be added, or
additional options may be added to variable responses. As these
changes occur, the CCDE version number will change.
When a change in CCDE versions occurs, Item 12.1 should not be
changed to reflect the new version, but continue to indicate the
version in which the record was originally collected.
EXAMPLE:
Clinical data for a client was collected in March 2006: 100.
REVISION HISTORY:
CCDE version
Date of revision
Type of revision
1.00
02/06/2006
Add new
Version 1.01
April 2006
Chapter 2 – CCDE Field Descriptions
155
Section 12 - Record Information
156
Chapter 2 – CCDE Field Descriptions
Version 1.01
April 2006
APPENDIX C
CCDE DATA DEFINITION TABLE
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Table of Contents:
Section 1
Program and Enrollment Data......................................................................................C-2
Section 2
Client and Record Identification ...................................................................................C-4
Section 3
Demographic Information.............................................................................................C-4
Section 4
Screening History.........................................................................................................C-6
Section 5
Colorectal Cancer Risk Factors....................................................................................C-8
Section 6
Screening and Diagnostic Tests Provided ...................................................................C-9
Section 7
Diagnosis Information for All Polyps/Lesions .............................................................C-21
Section 8
Diagnosis Information for Surgeries Performed to Complete Diagnosis ....................C-52
Section 9
Final Diagnosis...........................................................................................................C-53
Section 10
Diagnosis Information for Cancer/High Grade Dysplasia ...........................................C-55
Section 11
Treatment Information................................................................................................C-57
Section 12
Record Information.....................................................................................................C-58
CCDE Version 1.01
C-1
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
1. Program and Enrollment Data – Complete for each CCDE record
1.1
Program
3
1
3
001 = Baltimore, MD
002 = St. Louis, MO
003 = State of NE
004 = Stony Brook, NY
005 = Seattle and King County, WA
Valid code for your program.
8
4
11
MMDDYYYY
“MMDDYYYY”, “MM YYYY” or “YYYY”, but
not blank.
Unique identifier for each program.
1.2
Date of eligibility
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
The date that the client was
determined to be eligible to be
screened in the program. This could
be the date of the initial interview or
the date that an enrollment form
was filled out.
1.3.1
Knowledge of program (1)
Indicates how client learned about
the program.
2
12
13
1 = Doctor
2 = Other health care provider
3 = NBCCEDP
4 = Family member
5 = Friend
6 = Radio
7 = Television
8 = Magazine article
9 = Newspaper
10 = Mailing/flyer
11 = Community event
12 = Other
Range check.
Right justify
CCDE Version 1.01
C-2
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
1.3.2
Variable Name
Knowledge of program (2)
Column
Length
Begin
End
2
14
15
Indicates how client learned about
the program.
Use this field if client indicates that
he/she learned about the program
from more than one source.
Codes / Format / Comments
1 = Doctor
2 = Other health care provider
3 = NBCCEDP
4 = Family member
5 = Friend
6 = Radio
7 = Television
8 = Magazine article
9 = Newspaper
10 = Mailing/flyer
11 = Community event
12 = Other
Edit Checks / Skip Patterns
Range check.
Right justify
1.3.3
Knowledge of program (3)
2
16
17
Indicates how client learned about
the program.
Use this field if client indicates that
he/she learned about the program
from more than two sources.
1 = Doctor
2 = Other health care provider
3 = NBCCEDP
4 = Family member
5 = Friend
6 = Radio
7 = Television
8 = Magazine article
9 = Newspaper
10 = Mailing/flyer
11 = Community event
12 = Other
Range check.
Right justify
1.3.4
Knowledge of program other text
field
25
18
42
If “Knowledge of program” = 12, then enter the description in free text
format.
If 1.3.1, 1.3.2 or 1.3.3 = 12, this field should
be completed. Otherwise, leave blank.
Alphanumeric, left justify
Reserved for future use
CCDE Version 1.01
10
43
52
Leave blank.
C-3
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
2. Client and Record Identification- Complete for each CCDE record
2.1
Client identifier
15
53
67
System generated ID for each client
and will be consistent for client
throughout database.
If Social Security Number (SSN) is used, it must be encoded. The ID
number should be unique and constant for each client in order to track the
client over time. This field should not contain any identifiable information,
including partial names or dates.
Alphanumeric (no special symbols), left justify
Alphabetic characters must be entered consistently in uppercase or
lowercase for all records for each client.
2.2
Record identifier
6
68
73
This field will be used to uniquely identify one record among many for a
client. This can be a visit date or a sequential record number.
Each CCDE record identifies a
unique CRC “cycle” for a client. A
client can have multiple “cycles”.
Numeric, right justify
Reserved for future use
10
74
83
Leave blank.
3. Demographic Information – Complete for each CCDE record, and MUST be self-reported by client
3.1
Date of birth
8
84
91
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
Date of birth for the client.
3.2
Gender
1
92
92
1 = Male
2 = Female
9 = Other/unknown
Range check.
1
93
93
1 = Yes
2 = No
9 = Unknown/missing
Range check.
Indicates gender of client.
3.3
Hispanic or Latino origin
Indicates self-reported Hispanic or
Latino origin of client.
CCDE Version 1.01
“MMDDYYYY”, “MM YYYY” or “YYYY”, but
not blank.
MMDDYYYY
C-4
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
3.4.1
Variable Name
Race 1
Column
Length
Begin
End
1
94
94
The first of five (5) race fields used
to capture the self-reported race(s)
of a client.
Codes / Format / Comments
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
9 = Unknown
Edit Checks / Skip Patterns
Range check.
This field should be populated first. If a
client self-identifies more than one race,
then each race identified should be
reported in a separate race field.
Note: Racial groups are OMB-defined. No primary race is collected.
Race 1 has no significance over Race 2-5, and may simply be the first
race mentioned.
3.4.2
Race 2
1
95
95
Complete field if client self-identifies
more than one race.
3.4.3
Race 3
1
96
96
Complete field if client self-identifies
more than two races.
3.4.4
Race 4
1
97
97
Complete field if client self-identifies
more than three races.
3.4.5
Race 5
1
98
98
Complete field if client self-identifies
more than four races.
3.5
State of residence
2
99
100
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
Range check.
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
Range check.
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
Range check.
1 = White
2 = Black or African American
3 = Asian
4 = Native Hawaiian or Other Pacific Islander
5 = American Indian or Alaska Native
Range check.
2-digit FIPS code (If unknown, blank fill)
Valid FIPS code for state.
This field should be left blank, unless the
client reports more than one race.
This field should be left blank, unless the
client reports more than two races.
This field should be left blank, unless the
client reports more than three races.
This field should be left blank, unless the
client reports more than four races.
Client’s state of residence.
Right justify
3.6
County of residence
3
101
103
3-digit FIPS code (If unknown, blank fill)
Valid FIPS county code for state in 3.5.
Client’s county of residence.
Right justify
Reserved for future use
CCDE Version 1.01
10
104
113
Leave blank.
C-5
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
4. Screening History – Complete for each CCDE record. This information can be self-reported, or can come from information documented in the client’s medical record (preferred).
4.1.1
Previous take-home CRC fecal
test (FOBT/FIT)
1
114
114
1 = Yes
2 = No
9 = Unknown
Range check.
6
115
120
MMYYYY
If 4.1.1 = 1, then “MMYYYY” or “YYYY”.
If just the year is known, blank fill the month (e.g., 2006).
Leave blank if 4.1.1 = 2, 9
1 = Normal/negative test
2 = Abnormal/positive test result
9 = Unknown
Range check.
Information on most recent previous
take-home CRC fecal testing
(FOBT/FIT).
4.1.2
Previous take-home CRC fecal
test date
Most recent date for previous takehome CRC fecal test indicated in
4.1.1. This can be any date that the
client remembers.
4.1.3
Previous take-home CRC fecal
test result
1
121
121
Leave blank if 4.1.1 = 2, 9
Result of most recent previous
take-home CRC fecal test indicated
in 4.1.1.
4.2.1
Previous sigmoidoscopy
1
122
122
1 = Yes
2 = No
9 = Unknown
Range check.
6
123
128
MMYYYY
If 4.2.1 = 1, then “MMYYYY” or “YYYY”.
If just the year is known, blank fill the month (e.g., 2006).
Leave blank if 4.2.1 = 2, 9
1 = Normal/negative/results other than polyp(s), tumor(s), or cancer
2 = Polyp(s)/tumor(s)/cancer
3 = Incomplete
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
Information on most recent previous
sigmoidoscopy.
4.2.2
Previous sigmoidoscopy test
date
Most recent date for previous
sigmoidoscopy indicated in 4.2.1.
4.2.3
Result of previous
sigmoidoscopy
1
129
129
Result of most recent previous
sigmoidoscopy indicated in 4.2.1.
4.3.1
Previous colonoscopy
Information on most recent previous
colonoscopy.
CCDE Version 1.01
1
130
130
C-6
Leave blank if 4.2.1 = 2, 9
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
4.3.2
Variable Name
Previous colonoscopy test date
Column
Length
Begin
End
6
131
136
Most recent date for previous
colonoscopy indicated in 4.3.1.
4.3.3
Result of previous colonoscopy
1
137
137
Result of most recent previous
colonoscopy indicated in 4.3.1.
4.4.1
Previous DCBE
Previous DCBE test date
Result of previous DCBE
CCDE Version 1.01
If 4.3.1 = 1, then “MMYYYY” or “YYYY”.
If just the year is known, blank fill the month (e.g., 2006).
Leave blank if 4.3.1 = 2, 9
1 = Normal/negative/results other than polyp(s), tumor(s), or cancer
2 = Polyp(s)/tumor(s)/cancer
3 = Incomplete
9 = Unknown
Range check.
Leave blank if 4.3.1 = 2, 9
138
1 = Yes
2 = No
9 = Unknown
Range check.
6
139
144
MMYYYY
If 4.4.1 = 1, then “MMYYYY” or “YYYY”.
If just the year is known, blank fill the month (e.g., 2006).
Leave blank if 4.4.1 = 2, 9
1 = Normal/negative/results other than polyp(s), tumor(s), or cancer
2 = Polyp(s)/tumor(s)/cancer
3 = Incomplete
9 = Unknown
Range check.
1
145
145
Result of most recent previous
DCBE indicated in 4.4.1.
Reserved for future use
MMYYYY
138
Most recent date for previous
DCBE indicated in 4.4.1.
4.4.3
Edit Checks / Skip Patterns
1
Information on most recent previous
DCBE.
4.4.2
Codes / Format / Comments
10
146
155
Leave blank if 4.4.1 = 2, 9
Leave blank.
C-7
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
5. Colorectal Cancer Risk Factors – Complete for each CCDE record. This information can be self-reported, or can come from information documented in the client’s medical record (preferred).
5.1.1
Personal history of CRC
1
156
156
1 = Yes
2 = No
9 = Unknown
Range check.
4
157
160
YYYY
If 5.1.1 = 1, then “YYYY”.
Has client ever been diagnosed with
colorectal cancer?
5.1.2
Year CRC diagnosed
Leave blank if 5.1.1 = 2,9
Year (most recent occurrence) that
CRC was diagnosed.
5.2.1
Personal history of polyp(s)
1
161
161
1 = Yes
2 = No
9 = Unknown
Range check.
2
162
163
1 – 49 = Number of polyps
50 = ≥ 50 polyps
91 = < 10 polyps (if exact number not known)
92 = ≥ 10 polyps (if exact number not known)
99 = Unknown
Range check.
Has client ever been diagnosed with
colorectal polyp(s)?
5.2.2
Largest number of polyps
diagnosed during a single
procedure
Leave blank if 5.2.1 = 2, 9
Right justify
5.2.3
5.3
Were any of these polyps
adenomatous?
High risk due to family history of
CRC
1
164
164
1
165
165
10
166
175
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
Leave blank if 5.2.1 = 2, 9
Is this client considered to be at
high-risk because of a family history
of CRC?*
*Each program will have their own
documented definition of high-risk
due to family history of CRC.
Reserved for future use
CCDE Version 1.01
Leave blank.
C-8
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
6. Screening and Diagnostic Tests Provided – Complete for each CCDE record
6.0
Initial test recommended
1
176
176
1 = Take-home FOBT
2 = Take-home FIT
3 = Sigmoidoscopy
4 = Colonoscopy
5 = DCBE
9 = Unknown
Range check.
1
177
177
1 = Screening
2 = Surveillance after a positive colonoscopy
9 = Unknown
Range check.
1
178
178
1 = Take-home FOBT
2 = Take-home FIT
3 = Sigmoidoscopy
4 = Colonoscopy
5 = DCBE
Range check.
8
179
186
MMDDYYYY
“MMDDYYYY”, “MM YYYY” or “YYYY”, but
not blank.
The initial test recommended to the
individual by the program.
6.1.0
st
Indication for 1 test provided
This is the indication for the actual
test provided reported in 6.1.01.
“Provided = Paid For” (i.e. could be
a screening FOBT mailed, but not
returned).
6.1.01
st
1 test provided
The actual first test provided
through the program. “Provided =
Paid For” (i.e. could be a screening
FOBT mailed, but not returned).
6.1.02
st
Date of 1 test
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
Either the date of the procedure, the
date that the take-home FOBT/FIT
test was processed, or the date the
FOBT/FIT results were received.
6.1.03
Provider specialty
The specialty of the clinician
st
providing the 1 test.
2
187
188
1
2
3
4
5
6
7
8
9
10
11
99
=
=
=
=
=
=
=
=
=
=
=
=
General practitioner
Internist
Family practitioner
Gastroenterologist
General surgeon
Colorectal surgeon
Licensed practical nurse
Registered nurse
Nurse practitioner
Physician assistant
Administrator, if FOBT/FIT mailed by non-clinician
Unknown
Range check.
Right justify
CCDE Version 1.01
C-9
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.1.04
Variable Name
Clinical practice site
Column
Results of take-home FOBT/FIT
End
1
189
189
1 = Doctor’s office
2 = Ambulatory endoscopy/surgery center
3 = Hospital
4 = Health clinic
5 = Administrator, if FOBT/FIT mailed by non-clinician
9 = Unknown
Range check.
1
190
190
1 = Normal/negative
2 = Positive
3 = Refused
4 = Did not return card
5 = Pending
9 = Unknown
Range check.
1 = Normal/negative/diverticulosis/hemorrhoids
2 = Other finding not suggestive of cancer/polyp(s)
3 = Polyp(s)/suspicious for cancer/presumed cancer
4 = No findings/inconclusive
5 = Pending
9 = Unknown
Range check.
This question is answered if 6.1.01
was a take-home FOBT or FIT.
6.1.06
Results of endoscopy or DCBE
Edit Checks / Skip Patterns
Begin
The type of clinical practice where
st
the 1 test was provided.
6.1.05
Codes / Format / Comments
Length
1
191
191
This question is answered if 6.1.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
Leave blank if 6.1.01 = 3, 4, 5
Leave blank if 6.1.01 = 1, 2
NOTE: If more than one result, report the worst.
6.1.07
Was the bowel preparation
considered adequate by the
clinician performing the
endoscopy or DCBE?
1
192
192
Was the cecum reached during
the initial colonoscopy?
*Procedure report must explicitly state that the bowel prep was adequate,
otherwise report 9 (Unknown).
1
193
193
This question is answered if 6.1.01
was a colonoscopy.
6.1.09
Complications of endoscopy or
DCBE
Leave blank if 6.1.01 = 1, 2
Adequacy will be determined by the clinician performing the test.
This question is answered if 6.1.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
6.1.08
Range check.
1 = Yes*
2 = No
9 = Unknown
1 = Yes*
2 = No
9 = Unknown
Range check.
Leave blank if 6.1.01 = 1, 2, 3, 5
*Procedure report must explicitly state that the cecum was reached,
otherwise report 9 (Unknown).
1
194
194
1 = Yes
2 = No/unknown
Range check.
Leave blank if 6.1.01 = 1, 2
This question is answered if 6.1.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
CCDE Version 1.01
C-10
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.1.10
Variable Name
Was a biopsy/polypectomy
performed during the
endoscopy?
Column
Length
Begin
End
1
195
195
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Yes
2 = No
9 = Unknown
Range check.
0 = Biopsy performed, no specimens sent
1 - 97 = Number of specimens
98 = ≥ 98 specimens
99 = Unknown
Range check.
Leave blank if 6.1.01 = 1, 2, 5
This question is answered if 6.1.01
was a colonoscopy or a
sigmoidoscopy.
6.1.11
Number of specimens sent to
pathology (from endoscopy)
2
196
197
This question is answered if 6.1.01
was a colonoscopy or a
sigmoidoscopy, and a
biopsy/polypectomy was performed.
Leave blank if 6.1.01 = 1, 2, 5
Leave blank if 6.1.10 = 2, 9
Right justify
Includes samples removed entirely
or in part. If a single polyp is
removed piecemeal you would
report the number of specimens
(not the number of polyps).
6.1.12
Completeness of polyp removal
(from colonoscopy)
1
198
198
Range check.
1 = Yes
2 = No
9 = Unknown
Leave blank if 6.1.01 = 1, 2, 3, 5
Were all the polyps completely
st
removed during 1 test if it was a
colonoscopy?
6.1.13
Recommended next follow-up
procedure within this cycle after
st
1 test
The next follow-up procedure
recommended to the client (within
the cycle). This can be a diagnostic
follow-up test following a positive
initial test, or surgery to complete
diagnosis.
CCDE Version 1.01
Leave blank if 6.1.06 ≠ 3, 4
1
199
199
1 = Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to complete diagnosis*
8 = None (cycle is complete)
Range check.
If response = 4 or 8, then 6.2.01, 6.3.01
and 6.4.01 should = 0 (None).
* Diagnosis Information for Surgeries Performed to Complete
Diagnosis section must be completed if surgery is recommended.
C-11
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.2.01
6.2.02
Variable Name
nd
Column
Length
End
200
200
“Provided = Paid For”
NOTE: FOBT/FIT can not be a second, third or fourth test in a “cycle”.
nd
Date of 2
8
test
201
208
If response = 0 (None), then 6.2.02
through 6.2.13 should be blank.
“MMDDYYYY”, “MM YYYY” or “YYYY”, but
not blank.
MMDDYYYY
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
2
Provider specialty
Edit Checks / Skip Patterns
Range check.
The actual second test provided
through the program.
The date of the procedure.
6.2.03
Codes / Format / Comments
0 = None
3 = Sigmoidoscopy
4 = Colonoscopy
5 = DCBE
2
test provided within this cycle 1
Begin
209
210
The specialty of the clinician
nd
providing the 2 test.
1 = General practitioner
2 = Internist
3 = Family practitioner
4 = Gastroenterologist
5 = General surgeon
6 = Colorectal surgeon
7 = Licensed practical nurse
8 = Registered nurse
9 = Nurse practitioner
10 = Physician assistant
99 = Unknown
Range check.
Right justify
6.2.04
Clinical practice site
1
211
211
1 = Doctor’s office
2 = Ambulatory endoscopy/surgery center
3 = Hospital
4 = Health clinic
9 = Unknown
Range check.
1
212
212
1 = Normal/negative/diverticulosis/hemorrhoids
2 = Other finding not suggestive of cancer/polyp(s)
3 = Polyp(s)/suspicious for cancer/presumed cancer
4 = No findings/inconclusive
5 = Pending
9 = Unknown
Range check.
The type of clinical practice where
nd
the 2 test was provided.
nd
6.2.05
(Item not used for 2 test in “cycle”)
6.2.06
Results of endoscopy or DCBE
This question is answered if 6.2.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
NOTE: If more than one result, report the worst.
CCDE Version 1.01
C-12
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.2.07
Variable Name
Was the bowel preparation
considered adequate by the
clinician performing the
endoscopy or DCBE?
Column
Length
Begin
End
1
213
213
Was the cecum reached during
the colonoscopy?
Complications of endoscopy or
DCBE
Range check.
1 = Yes*
2 = No
9 = Unknown
*Procedure report must explicitly state that the bowel prep was adequate,
otherwise report 9 (Unknown).
1
214
214
This question is answered if 6.2.01
was a colonoscopy.
6.2.09
Edit Checks / Skip Patterns
Adequacy will be determined by the clinician performing the test.
This question is answered if 6.2.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
6.2.08
Codes / Format / Comments
1 = Yes*
2 = No
9 = Unknown
Range check.
Leave blank if 6.2.01 = 3, 5
*Procedure report must explicitly state that the cecum was reached,
otherwise report 9 (Unknown).
1
215
215
1 = Yes
2 = No/unknown
Range check.
1
216
216
1 = Yes
2 = No
9 = Unknown
Range check.
0 = Biopsy performed, no specimens sent
1 - 97 = Number of specimens
98 = ≥ 98 specimens
99 = Unknown
Range check.
This question is answered if 6.2.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
6.2.10
Was a biopsy/polypectomy
performed during the
endoscopy?
Leave blank if 6.2.01 = 5
This question is answered if 6.2.01
was a colonoscopy or a
sigmoidoscopy.
6.2.11
Number of specimens sent to
pathology (from endoscopy)
This question is answered if 6.2.01
was a colonoscopy or a
sigmoidoscopy, and a
biopsy/polypectomy was performed.
2
217
218
Leave blank if 6.2.01 = 5
Leave blank if 6.2.10 = 2, 9
Right justify
Includes samples removed entirely
or in part. If a single polyp is
removed piecemeal you would
report the number of specimens
(not the number of polyps).
CCDE Version 1.01
C-13
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.2.12
Variable Name
Completeness of polyp removal
(from colonoscopy)
Column
Length
Begin
End
1
219
219
Codes / Format / Comments
Range check.
1 = Yes
2 = No
9 = Unknown
Leave blank if 6.2.01 = 3, 5
Were all the polyps completely
nd
removed during 2 test if it was a
colonoscopy?
6.2.13
Recommended next follow-up
procedure within this cycle after
nd
2 test.
The next follow-up procedure
recommended to the client (within
the cycle). This can be another
diagnostic follow-up test or surgery
to complete diagnosis.
CCDE Version 1.01
Edit Checks / Skip Patterns
Leave blank if 6.2.06 ≠ 3, 4
1
220
220
1 = Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to complete diagnosis*
8 = None (cycle is complete)
Range check.
If response = 4 or 8, then 6.3.01 and 6.4.01
should = 0 (None).
* Diagnosis Information for Surgeries Performed to Complete
Diagnosis section must be completed if surgery is recommended.
C-14
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.3.01
6.3.02
Variable Name
rd
Column
Length
Begin
End
1
221
221
The actual third test provided
through the program.
“Provided = Paid For"
NOTE: FOBT/FIT can not be a second, third or fourth test in a “cycle”.
rd
Date of 3
8
test
222
229
If response = 0 (None), then 6.3.02
through 6.3.13 should be blank.
“MMDDYYYY”, “MM YYYY” or “YYYY”, but
not blank.
MMDDYYYY
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
2
Provider specialty
Edit Checks / Skip Patterns
Range check.
0 = None
3 = Sigmoidoscopy
4 = Colonoscopy
5 = DCBE
3 test provided within this cycle
The date of the procedure.
6.3.03
Codes / Format / Comments
230
231
The specialty of the clinician
rd
providing the 3 test.
1 = General practitioner
2 = Internist
3 = Family practitioner
4 = Gastroenterologist
5 = General surgeon
6 = Colorectal surgeon
7 = Licensed practical nurse
8 = Registered nurse
9 = Nurse practitioner
10 = Physician assistant
99 = Unknown
Range check.
Right justify
6.3.04
Clinical practice site
1
232
232
1 = Doctor’s office
2 = Ambulatory endoscopy/surgery center
3 = Hospital
4 = Health clinic
9 = Unknown
Range check.
1
233
233
1 = Normal/negative/diverticulosis/hemorrhoids
2 = Other finding not suggestive of cancer/polyp(s)
3 = Polyp(s)/suspicious for cancer/presumed cancer
4 = No findings/inconclusive
5 = Pending
9 = Unknown
Range check.
The type of clinical practice where
rd
the 3 test was provided.
rd
6.3.05
(Item not used for 3 test in “cycle”)
6.3.06
Results of endoscopy or DCBE
This question is answered if 6.3.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
NOTE: If more than one result, report the worst.
CCDE Version 1.01
C-15
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.3.07
Variable Name
Was the bowel preparation
considered adequate by the
clinician performing the
endoscopy or DCBE?
Column
Length
Begin
End
1
234
234
Was the cecum reached during
the colonoscopy?
Complications of endoscopy or
DCBE
Range check.
1 = Yes*
2 = No
9 = Unknown
*Procedure report must explicitly state that the bowel prep was adequate,
otherwise report 9 (Unknown).
1
235
235
This question is answered if 6.3.01
was a colonoscopy.
6.3.09
Edit Checks / Skip Patterns
Adequacy will be determined by the clinician performing the test.
This question is answered if 6.3.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
6.3.08
Codes / Format / Comments
1 = Yes*
2 = No
9 = Unknown
Range check.
Leave blank if 6.3.0 1 = 3, 5
*Procedure report must explicitly state that the cecum was reached,
otherwise report 9 (Unknown).
1
236
236
1 = Yes
2 = No/unknown
Range check.
1
237
237
1 = Yes
2 = No
9 = Unknown
Range check.
0 = Biopsy performed, no specimens sent
1 - 97 = Number of specimens
98 = ≥ 98 specimens
99 = Unknown
Range check.
This question is answered if 6.3.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
6.3.10
Was a biopsy/polypectomy
performed during the
endoscopy?
Leave blank if 6.3.01 = 5
This question is answered if 6.3.01
was a colonoscopy or a
sigmoidoscopy.
6.3.11
Number of specimens sent to
pathology (from endoscopy)
This question is answered if 6.3.01
was a colonoscopy or a
sigmoidoscopy, and a
biopsy/polypectomy was performed.
2
238
239
Leave blank if 6.3.01 = 5
Leave blank if 6.3.10 = 2, 9
Right justify
Includes samples removed entirely
or in part. If a single polyp is
removed piecemeal you would
report the number of specimens
(not the number of polyps).
CCDE Version 1.01
C-16
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.3.12
Variable Name
Completeness of polyp removal
(from colonoscopy)
Column
Length
Begin
End
1
240
240
Codes / Format / Comments
Range check.
1 = Yes
2 = No
9 = Unknown
Leave blank if 6.3.01 = 3, 5
Were all the polyps completely
rd
removed during 3 test if it was a
colonoscopy?
6.3.13
Recommended next follow-up
procedure within this cycle after
rd
3 test.
The next follow-up procedure
recommended to the client (within
the cycle). This can be another
diagnostic follow-up test or surgery
to complete diagnosis.
CCDE Version 1.01
Edit Checks / Skip Patterns
Leave blank if 6.3.06 ≠ 3, 4
1
241
241
1 = Sigmoidoscopy
2 = Colonoscopy
3 = DCBE
4 = Surgery to complete diagnosis*
8 = None (cycle is complete)
Range check.
If response = 4 or 8, then 6.4.01 should = 0
(None).
* Diagnosis Information for Surgeries Performed to Complete
Diagnosis section must be completed if surgery is recommended.
C-17
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.4.01
6.4.02
Variable Name
th
Column
Length
Begin
End
1
242
242
The actual fourth test provided
through the program.
“Provided = Paid For”.
NOTE: FOBT/FIT can not be a second, third or fourth test in a “cycle”.
th
8
Date of 4 test
243
250
If response = 0 (None), then 6.4.02
through 6.4.13 should be blank.
“MMDDYYYY”, “MM YYYY” or “YYYY”, but
not blank.
MMDDYYYY
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
2
Provider specialty
Edit Checks / Skip Patterns
Range check.
0 = None
3 = Sigmoidoscopy
4 = Colonoscopy
5 = DCBE
4 test provided within this cycle
The date of the procedure.
6.4.03
Codes / Format / Comments
251
252
The specialty of the clinician
th
providing the 4 test.
1 = General practitioner
2 = Internist
3 = Family practitioner
4 = Gastroenterologist
5 = General surgeon
6 = Colorectal surgeon
7 = Licensed practical nurse
8 = Registered nurse
9 = Nurse practitioner
10 = Physician assistant
99 = Unknown
Range check.
Right justify
6.4.04
Clinical practice site
1
253
253
1 = Doctor’s office
2 = Ambulatory endoscopy/surgery center
3 = Hospital
4 = Health clinic
9 = Unknown
Range check.
1
254
254
1 = Normal/negative/diverticulosis/hemorrhoids
2 = Other finding not suggestive of cancer/polyp(s)
3 = Polyp(s)/suspicious for cancer/presumed cancer
4 = No findings/inconclusive
5 = Pending
9 = Unknown
Range check.
The type of clinical practice where
th
the 4 test was provided.
th
6.4.05
(Item not used for 4 test in “cycle”)
6.4.06
Results of endoscopy or DCBE
This question is answered if 6.4.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
NOTE: If more than one result, report the worst.
CCDE Version 1.01
C-18
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.4.07
Variable Name
Was the bowel preparation
considered adequate by the
clinician performing the
endoscopy or DCBE?
Column
Length
Begin
End
1
255
255
Was the cecum reached during
the colonoscopy?
Complications of endoscopy or
DCBE
Range check.
1 = Yes*
2 = No
9 = Unknown
*Procedure report must explicitly state that the bowel prep was adequate,
otherwise report 9 (Unknown).
1
256
256
This question is answered if 6.4.01
was a colonoscopy.
6.4.09
Edit Checks / Skip Patterns
Adequacy will be determined by the clinician performing the test.
This question is answered if 6.4.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
6.4.08
Codes / Format / Comments
1 = Yes*
2 = No
9 = Unknown
Range check.
Leave blank if 6.4.01 = 3, 5
*Procedure report must explicitly state that the cecum was reached,
otherwise report 9 (Unknown).
1
257
257
1 = Yes
2 = No/unknown
Range check.
1
258
258
1 = Yes
2 = No
9 = Unknown
Range check.
0 = Biopsy performed, no specimens sent
1 - 97 = Number of specimens
98 = ≥ 98 specimens
99 = Unknown
Range check.
This question is answered if 6.4.01
was a colonoscopy, a
sigmoidoscopy or a DCBE.
6.4.10
Was a biopsy/polypectomy
performed during the
endoscopy?
Leave blank if 6.4.01 = 5
This question is answered if 6.4.01
was a colonoscopy or a
sigmoidoscopy.
6.4.11
Number of specimens sent to
pathology (from endoscopy)
This question is answered if 6.4.01
was a colonoscopy or a
sigmoidoscopy, and a
biopsy/polypectomy was performed.
2
259
260
Leave blank if 6.4.01 = 5
Leave blank if 6.4.10 = 2, 9
Right justify
Includes samples removed entirely
or in part. If a single polyp is
removed piecemeal you would
report the number of specimens
(not the number of polyps).
CCDE Version 1.01
C-19
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
6.4.12
Variable Name
Completeness of polyp removal
(from colonoscopy)
Column
Length
Begin
End
1
261
261
Codes / Format / Comments
Range check.
1 = Yes
2 = No
9 = Unknown
Leave blank if 6.4.01 = 3, 5
Were all the polyps completely
th
removed during 4 test if it was a
colonoscopy?
6.4.13
Recommended next follow-up
th
procedure after 4 test.
Leave blank if 6.4.06 ≠ 3, 4
1
262
262
The next follow-up procedure
recommended to the client. This
can be another diagnostic follow-up
test or surgery to complete
diagnosis.
Reserved for future use
CCDE Version 1.01
Edit Checks / Skip Patterns
4 = Surgery to complete diagnosis*
8 = None (cycle is complete)
Range check.
* Diagnosis Information for Surgeries Performed to Complete
Diagnosis section must be completed if surgery is recommended.
10
263
Leave blank.
272
C-20
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
7. Diagnosis Information for All Polyps/Lesions – Complete for each CCDE record
7.0
Total number of polyps/lesions
2
273
274
Total number of unique
polyps/lesions identified through all
colonoscopies and/or
sigmoidoscopies during the client’s
“cycle”.
0 = No polyps/lesions
1 – 96 = Number of polyps/lesions
97 = ≥ 97 polyps/lesions
98 = At least one polyp/lesion, exact number not known
99 = Unknown
Range check.
Specimens from surgical resections do not belong in this section.
Right justify
7.01.1
st
Location of 1 polyp/lesion
2
275
276
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.01.2
st
Size of 1 polyp/lesion
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
CCDE Version 1.01
2
277
278
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
C-21
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.01.3.1
Column
Variable Name
st
Procedure for removal of 1
polyp/lesion (1)
Length
Begin
End
1
279
279
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
7.01.3.2
st
Procedure for removal of 1
polyp/lesion (2)
1
280
280
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.01.3.3
st
Procedure for removal of 1
polyp/lesion (3)
1
281
281
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.01.4
st
Was 1 polyp/lesion completely
removed?
CCDE Version 1.01
1
282
282
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
C-22
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.01.5
Variable Name
st
Histology of 1 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
Column
Length
Begin
End
2
283
284
Codes / Format / Comments
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-23
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.02.1
Column
Variable Name
nd
Location of 2
polyp/lesion
Length
Begin
End
2
285
286
Complete only if more than one
polyp/lesion was removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.02.2
Size of 2
nd
2
polyp/lesion
287
288
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
nd
Procedure for removal of 2
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.02.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
289
289
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-24
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.02.3.2
Column
Variable Name
nd
Procedure for removal of 2
polyp/lesion (2)
Length
Begin
End
1
290
290
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.02.3.3
nd
Procedure for removal of 2
polyp/lesion (3)
1
291
291
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.02.4
7.02.5
nd
Was 2 polyp/lesion completely
removed?
Histology of 2
nd
polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
292
293
292
294
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-25
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.03.1
Column
Variable Name
rd
Location of 3 polyp/lesion
Length
Begin
End
2
295
296
Complete only if more than two
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.03.2
rd
2
Size of 3 polyp/lesion
297
298
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
rd
Procedure for removal of 3
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.03.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
299
299
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-26
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.03.3.2
Column
Variable Name
rd
Procedure for removal of 3
polyp/lesion (2)
Length
Begin
End
1
300
300
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.03.3.3
rd
Procedure for removal of 3
polyp/lesion (3)
1
301
301
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.03.4
7.03.5
rd
Was 3 polyp/lesion completely
removed?
rd
Histology of 3 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
302
303
302
304
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-27
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.04.1
Column
Variable Name
th
Location of 4 polyp/lesion
Length
Begin
End
2
305
306
Complete only if more than three
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.04.2
th
2
Size of 4 polyp/lesion
307
308
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 4
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.04.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
309
309
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-28
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.04.3.2
Column
Variable Name
th
Procedure for removal of 4
polyp/lesion (2)
Length
Begin
End
1
310
310
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.04.3.3
th
Procedure for removal of 4
polyp/lesion (3)
1
311
311
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.04.4
7.04.5
th
Was 4 polyp/lesion completely
removed?
th
Histology of 4 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
312
313
312
314
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-29
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.05.1
Column
Variable Name
th
Location of 5 polyp/lesion
Length
Begin
End
2
315
316
Complete only if more than four
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Location will generally be found on
the endoscopy report.
7.05.2
th
317
318
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 5
polyp/lesion (1)
th
Procedure for removal of 5
polyp/lesion (2)
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Leave blank if 7.0 = 0
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
Range check.
Leave blank if 7.0 = 0
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
1
319
319
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
7.05.3.2
Range check.
Right justify
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.05.3.1
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Right justify
2
Size of 5 polyp/lesion
Codes / Format / Comments
1
320
320
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
C-30
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.05.3.3
Column
Variable Name
th
Procedure for removal of 5
polyp/lesion (3)
Length
Begin
End
1
321
321
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.05.4
7.05.5
th
Was 5 polyp/lesion completely
removed?
th
Histology of 5 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
322
323
322
324
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-31
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.06.1
Column
Variable Name
th
Location of 6 polyp/lesion
Length
Begin
End
2
325
326
Complete only if more than five
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.06.2
th
2
Size of 6 polyp/lesion
327
328
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 6
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.06.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
329
329
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-32
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.06.3.2
Column
Variable Name
th
Procedure for removal of 6
polyp/lesion (2)
Length
Begin
End
1
330
330
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.06.3.3
th
Procedure for removal of 6
polyp/lesion (3)
1
331
331
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
th
7.06.4
Was 6 polyp/lesion completely
removed?
7.06.5
Histology of 6 polyp/lesion
th
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
1
332
332
1 = Yes
2 = No
9 = Unknown
Range check. Leave blank if 7.0 = 0
2
333
334
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-33
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.07.1
Column
Variable Name
th
Location of 7 polyp/lesion
Length
Begin
End
2
335
336
Complete only if more than six
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.07.2
th
2
Size of 7 polyp/lesion
337
338
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 7
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.07.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
339
339
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-34
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.07.3.2
Column
Variable Name
th
Procedure for removal of 7
polyp/lesion (2)
Length
Begin
End
1
340
340
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.07.3.3
th
Procedure for removal of 7
polyp/lesion (3)
1
341
341
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.07.4
7.07.5
th
Was 7 polyp/lesion completely
removed?
th
Histology of 7 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
342
343
342
344
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-35
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.08.1
Column
Variable Name
th
Location of 8 polyp/lesion
Length
Begin
End
2
345
346
Complete only if more than seven
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.08.2
th
2
Size of 8 polyp/lesion
347
348
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 8
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.08.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
349
349
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-36
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.08.3.2
Column
Variable Name
th
Procedure for removal of 8
polyp/lesion (2)
Length
Begin
End
1
350
350
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.08.3.3
th
Procedure for removal of 8
polyp/lesion (3)
1
351
351
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.08.4
7.08.5
th
Was 8 polyp/lesion completely
removed?
th
Histology of 8 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
352
353
352
354
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-37
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.09.1
Column
Variable Name
th
Location of 9 polyp/lesion
Length
Begin
End
2
355
356
Complete only if more than eight
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.09.2
th
2
Size of 9 polyp/lesion
357
358
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 9
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.09.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
359
359
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-38
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.09.3.2
Column
Variable Name
th
Procedure for removal of 9
polyp/lesion (2)
Length
Begin
End
1
360
360
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.09.3.3
th
Procedure for removal of 9
polyp/lesion (3)
1
361
361
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.09.4
7.09.5
th
Was 9 polyp/lesion completely
removed?
th
Histology of 9 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
362
363
362
364
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-39
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.10.1
Column
Variable Name
th
Location of 10 polyp/lesion
Length
Begin
End
2
365
366
Complete only if more than nine
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.10.2
th
2
Size of 10 polyp/lesion
367
368
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 10
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.10.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
369
369
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-40
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.10.3.2
Column
Variable Name
th
Procedure for removal of 10
polyp/lesion (2)
Length
Begin
End
1
370
370
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.10.3.3
th
Procedure for removal of 10
polyp/lesion (3)
1
371
371
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.10.4
7.10.5
th
Was 10 polyp/lesion completely
removed?
th
Histology of 10 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
372
373
372
374
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-41
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.11.1
Column
Variable Name
th
Location of 11 polyp/lesion
Length
Begin
End
2
375
376
Complete only if more than ten
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.11.2
th
2
Size of 11 polyp/lesion
377
378
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 11
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.11.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
379
379
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-42
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.11.3.2
Column
Variable Name
th
Procedure for removal of 11
polyp/lesion (2)
Length
Begin
End
1
380
380
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.11.3.3
th
Procedure for removal of 11
polyp/lesion (3)
1
381
381
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.11.4
7.11.5
th
Was 11 polyp/lesion completely
removed?
th
Histology of 11 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
382
383
382
384
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-43
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.12.1
Column
Variable Name
th
Location of 12 polyp/lesion
Length
Begin
End
2
385
386
Complete only if more than eleven
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.12.2
th
2
Size of 12 polyp/lesion
387
388
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 12
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.12.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
389
389
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-44
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.12.3.2
Column
Variable Name
th
Procedure for removal of 12
polyp/lesion (2)
Length
Begin
End
1
390
390
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.12.3.3
th
Procedure for removal of 12
polyp/lesion (3)
1
391
391
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.12.4
7.12.5
th
Was 12 polyp/lesion completely
removed?
th
Histology of 12 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
392
393
392
394
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-45
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.13.1
Column
Variable Name
th
Location of 13 polyp/lesion
Length
Begin
End
2
395
396
Complete only if more than twelve
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.13.2
th
2
Size of 13 polyp/lesion
397
398
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 13
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.13.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
399
399
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-46
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.13.3.2
Column
Variable Name
th
Procedure for removal of 13
polyp/lesion (2)
Length
Begin
End
1
400
400
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.13.3.3
th
Procedure for removal of 13
polyp/lesion (3)
1
401
401
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.13.4
7.13.5
th
Was 13 polyp/lesion completely
removed?
th
Histology of 13 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
402
403
402
404
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-47
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.14.1
Column
Variable Name
th
Location of 14 polyp/lesion
Length
Begin
End
2
405
406
Complete only if more than thirteen
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.14.2
th
2
Size of 14 polyp/lesion
407
408
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 14
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.14.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
409
409
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-48
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.14.3.2
Column
Variable Name
th
Procedure for removal of 14
polyp/lesion (2)
Length
Begin
End
1
410
410
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.14.3.3
th
Procedure for removal of 14
polyp/lesion (3)
1
411
411
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.14.4
7.14.5
th
Was 14 polyp/lesion completely
removed?
th
Histology of 14 polyp/lesion
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
CCDE Version 1.01
1
2
412
413
412
414
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
C-49
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.15.1
Column
Variable Name
th
Location of 15 polyp/lesion
Length
Begin
End
2
415
416
Complete only if more than fourteen
polyps/lesions were removed.
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy report and pathology
report in order to “match up” the
correct polyps.
Codes / Format / Comments
1 = Rectum
2 = Rectosigmoid junction
3 = Sigmoid
4 = Descending
5 = Splenic flexure
6 = Transverse
7 = Hepatic flexure
8 = Ascending
9 = Cecum
10 = Appendix
11 = Overlapping lesions
99 = Unknown
Edit Checks / Skip Patterns
Range check.
Leave blank if 7.0 = 0
Location will generally be found on the endoscopy report.
Right justify
7.15.2
th
2
Size of 15 polyp/lesion
417
418
This is the diameter of the
polyp/lesion in millimeters (mm) or
the longest dimension of the
polyp/lesion if asymmetric.
th
Procedure for removal of 15
polyp/lesion (1)
This is the first procedure
performed during removal/biopsy of
the polyp/lesion.
CCDE Version 1.01
Range check.
Leave blank if 7.0 = 0
Right justify
NOTE: The individual translating clinical data into the CCDEs will need to
carefully compare the endoscopy report and pathology report in order to
“match up” the correct polyps. Size may be found on both the endoscopy
and pathology reports, but size from the endoscopy report is preferred. If
the specimen is not intact when sent to the pathology lab do NOT report
specimen size from the pathology report.
NOTE: This should be the size of
the actual polyp and not the size of
the biopsy specimen submitted for
pathology.
7.15.3.1
0 = < 1 mm
1 – 97 = Size of polyp/lesion in mm
98 = ≥ 98 mm
99 = Unknown
1
419
419
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
7 = Not biopsied or removed
9 = Unknown
C-50
Range check.
Leave blank if 7.0 = 0
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
7.15.3.2
Column
Variable Name
th
Procedure for removal of 15
polyp/lesion (2)
Length
Begin
End
1
420
420
This is the second procedure
performed during removal/biopsy of
the polyp/lesion.
7.15.3.3
th
Procedure for removal of 15
polyp/lesion (3)
1
421
421
This is the third procedure
performed during removal/biopsy of
the polyp/lesion.
7.15.4
7.15.5
th
Was 15 polyp/lesion completely
removed?
th
Histology of 15 polyp/lesion
1
2
422
423
422
424
This is the histology of the
polyp/lesion. If polyp was submitted
to pathology as piecemeal
fragments and more than one
histological diagnosis was reported,
report the worst (the response
options are listed in general order of
severity).
NOTE: The individual translating
clinical data into the CCDEs will
need to carefully compare the
endoscopy and pathology reports in
order to “match up” the correct
lesions.
Reserved for future use
CCDE Version 1.01
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Snare polypectomy
2 = Hot biopsy forceps or cautery
3 = Cold biopsy
4 = Ablation
5 = Submucosal injection
6 = Control of bleeding
9 = Unknown
Range check.
1 = Yes
2 = No
9 = Unknown
Range check.
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than one procedure was performed
during the polyp/lesion removal.
Leave blank if 7.0 = 0
NOTE: This field should only be completed
if more than two procedures were
performed during the polyp/lesion removal.
Leave blank if 7.0 = 0
Leave blank if 7.0 = 0
Do not update/change this variable if polyp
with high grade dysplasia is determined to
be cancer during a subsequent surgery.
Histologies for all polyps/lesions should be reviewed and a final
diagnosis recorded in Item 9.2.
Right justify
30
425
454
Leave blank.
C-51
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
8. Diagnosis Information for Surgeries Performed to Complete Diagnosis
8.1
Histology from surgical resection 2
455
456
This is the worst histopathological
diagnosis made from surgical
resection (the response options are
listed in general order of severity).
0 = Surgery recommended but not performed
1 = Normal or other non-polyp histology
2 = Non-adenomatous polyp (inflammatory, hamartomatous, etc.)
3 = Hyperplastic polyp
4 = Adenoma, NOS (no high grade dysplasia noted)
5 = Adenoma, tubular (no high grade dysplasia noted)
6 = Adenoma, mixed tubular villous (no high grade dysplasia noted)
7 = Adenoma, villous (no high grade dysplasia noted)
8 = Adenoma, serrated (no high grade dysplasia noted)
9 = Adenoma with high grade dysplasia (includes in situ carcinoma)
10 = Adenocarcinoma, invasive
11 = Carcinoma, other
99 = Unknown/other lesions ablated, not retrieved or confirmed
Range check.
If surgery was recommended in 6.1.13,
6.2.13, 6.3.13 or 6.4.13 but was not
completed, code 0 (Surgery recommended
but not performed).
If no surgery was recommended in 6.1.13,
6.2.13, 6.3.13 or 6.4.13, leave blank.
Use histology from surgical resection in conjunction with all of the
polyp/lesion histologies in the Diagnosis Information for All
Polyps/Lesions section, to report the “Final diagnosis” (9.2).
Right justify
8.2
Date surgery performed
8
457
464
The date of the surgical procedure
used to complete diagnosis
(recommended in 6.1.13, 6.2.13,
6.3.13 or 6.4.13).
MMDDYYYY
“MMDDYYYY”, “MM YYYY”, or “YYYY”.
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
If 6.1.13, 6.2.13, 6.3.13 or 6.4.13 = 4
(Surgery to complete diagnosis), then date
must be completed.
If no surgery was recommended in 6.1.13,
6.2.13, 6.3.13 or 6.4.13, then leave blank.
If 8.1 = 0, then leave blank.
Reserved for future use
CCDE Version 1.01
10
465
474
Leave blank.
C-52
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
End
475
475
Codes / Format / Comments
Edit Checks / Skip Patterns
9. Final Diagnosis – Completed for all CCDE records
9.1
Status of diagnosis
1
After all screening and diagnostic
tests were performed /offered to the
client, what is the status of the
client’s care?
1 = Complete (final diagnosis made)
2 = Pending final diagnosis
Ŧ
3 = Verbal/written refusal for any test needed to obtain a final diagnosis*
Ŧ
4 = Client moved before final diagnosis was made
Ŧ
5 = Client died before final diagnosis was made
Ŧ
6 = Lost to follow-up*
9 = Unknown
Range check.
If a client receives a single screening test
which is normal/negative, then complete
this field as 1 (Complete).
*Programs must have a policy in place to define how much time can
elapse before the client is deemed refused or lost to follow-up.
Ŧ
These items should have an administrative close-out date reported in 9.3
“Date of diagnosis”.
9.2
Final diagnosis
1
476
476
This is the final diagnosis after all
procedures have been completed
(including surgery, if done) that will
determine the re-screening or
surveillance test recommendation.
1 = Normal/negative
2
2 = Polyp, no high grade dysplasia
1,2
3 = Polyp with high grade dysplasia
1,2
4 = Cancer
1
Range check.
If the only test performed in cycle was
FOBT or FIT, then complete this field as 1
(Normal/negative).
Diagnosis Information for Cancer/High Grade Dysplasia section must
be completed if 9.2 “Final diagnosis” = 3, 4.
2
Treatment section must be completed if 9.2 “Final diagnosis” = 2, 3, 4.
9.3
Date of diagnosis
This can be the date of the final
pathology report, the date of the
‘normal’ screening test, or when the
client refused or was determined to
be lost to follow-up.
8
477
484
If 9.1 = 1, 3-6, then “MMDDYYYY”, “MM
YYYY” or “YYYY”.
MMDDYYYY
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
If 9.1 = 3-6, then an administrative closeout date will be necessary.
Leave blank if 9.1 = 2, 9
CCDE Version 1.01
C-53
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
9.4
Variable Name
Recommended screening or
surveillance test for next cycle
Column
Length
Begin
End
1
485
485
The next screening or surveillance
test recommended to the client at
the end of the cycle. This can be a
surveillance colonoscopy following
a previous abnormal colonoscopy
and/or surgery, or the next
screening test recommended to the
client following a normal/negative
test.
9.5
Indication for screening or
surveillance test for next cycle
1
486
486
Codes / Format / Comments
Edit Checks / Skip Patterns
1 = Take-home FOBT
2 = Take-home FIT
3 = Sigmoidoscopy
4 = Colonoscopy
5 = DCBE
6 = None
9 = Unknown
Range check.
1 = Screening
2 = Surveillance after a positive colonoscopy and/or surgery
Range check.
If client is terminally ill or for other reasons
no further tests are recommended, then
code this as 6 (None).
Leave blank if 9.1 ≠ 1
Leave blank if 9.1 ≠ 1
The indication for the next
screening or surveillance test
recommended to the client.
9.6
Number of months before
screening or surveillance test for
next cycle
Leave blank if 9.4 = 6, 9
3
487
489
CCDE Version 1.01
Range check.
Leave blank if 9.1 ≠ 1
Leave blank if 9.4 = 6, 9
The number of months
recommended between Date of
diagnosis (9.3) and next
recommended screening or
surveillance test.
Reserved for future use
12 – 180 = Actual number of months
999 = Unknown
Right Justify
10
490
499
Leave blank.
C-54
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
10. Diagnosis Information for Cancer/High Grade Dysplasia – Complete this section when Final Diagnosis (9.2) = 3 or 4
10.1
Stage at diagnosis/treatment
1
500
500
AJCC cancer stage used as a basis
for clinical decisions. This can be
based on clinical and/or
pathological information.
10.2
Recurrent cancers
Registry linkage status
Registry primary site
If “Final diagnosis” (9.2) = 3 (High grade
dysplasia) or 4 (Cancer), then 10.1 must be
completed.
501
501
1 = New CRC primary
2 = Recurrent CRC
3 = Non-CRC primary (metastasis from another organ)
9 = Unknown
Range check.
1
502
502
1 = Pending linkage
2 = Linked, matched
3 = Linked, not matched
Range check.
4
503
506
C000-C999
Range check.
Has this record been linked to the
state cancer registry?
10.4
Range check.
1
Is this cancer a new primary or a
recurrent cancer?
10.3
0 = Stage 0 (high grade dysplasia, severe dysplasia, or in situ)
1 = Stage I
2 = Stage II
3 = Stage III
4 = Stage IV
9 = Unknown/unstaged
Leave blank if 10.3 = 1, 3
Primary site [NAACCR data item
#400] obtained from the central
cancer registry.
NOTE: The ‘C’ must be included as part of the variable response in the
CCDE file. For example Cecum = C180. A complete list of valid
values/labels will be provided for reference in the CCDE User’s Manual.
See SEER Program Coding and
Staging Manual (pg 73):
http://seer.cancer.gov/manuals/SPM2004.p
df
10.5
Registry CS-derived SS2000
Collaborative stage (CS)-derived
summary stage 2001 [NAACCR
data item #3020] obtained from the
central cancer registry database.
See CS Staging Manual (pg 67) &
SEER Summary Staging Manual:
Alphanumeric, left justify
1
507
507
0 = In situ
1 = Localized
2 = Regional, direct extension only
3 = Regional, regional lymph nodes only
4 = Regional, extension and nodes
5 = Regional, NOS
7 = Distant
8 = Not applicable
9 = Unknown/unstaged
Range check.
Leave blank if 10.3 = 1, 3
http://www.cancerstaging.org/cstage/csman
ualpart1.pdf
http://seer.cancer.gov/tools/ssm/
CCDE Version 1.01
C-55
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
10.6
Variable Name
Registry CS-derived AJCC stage
group
Column
Length
Begin
End
2
508
509
Codes / Format / Comments
Edit Checks / Skip Patterns
Range check.
Range: 00-99
Leave blank if 10.3 = 1, 3
Collaborative stage (CS)-derived
AJCC stage [NAACCR date Item
#3000] obtained from the central
cancer registry database WHEN
AVAILABLE.
Valid values for CS-derived AJCC stage include: 00-02, 10-24, 30-43, 5063, 70-74, 88, 90, 99.
A complete list of valid values/labels will be provided for reference in the
CCDE User’s Manual.
See CS Staging Manual (pg 65):
http://www.cancerstaging.org/cstage/csman
ualpart1.pdf
10.7
Registry CS extension
2
510
511
Range check.
Range: 00-99
Leave blank if 10.3 = 1, 3
Collaborative stage (CS) extension
[NAACCR data item #2810]
obtained from the central cancer
registry database.
Valid values for CS extension include: 00, 05, 10-16, 20, 30, 40, 42, 45,
46, 50, 55, 57, 60, 65, 66, 70, 75, 80, 95, 99.
A complete list of valid values/labels will be provided for reference in the
CCDE User’s Manual.
See CS Staging Manual (pg 272):
http://www.cancerstaging.org/cstage/csman
ualpart2.pdf
10.8
Registry CS lymph nodes
2
512
513
Range check.
Range: 00-99
Leave blank if 10.3 = 1, 3
Collaborative stage (CS) lymph
nodes [NAACCR data item #2830]
obtained from the central cancer
registry database.
Valid values for CS lymph nodes include: 00, 10, 20, 30, 80, 99.
A complete list of valid values/labels will be provided for reference in the
CCDE User’s Manual.
See CS Staging Manual (pg 274):
http://www.cancerstaging.org/cstage/csman
ualpart2.pdf
10.9
Registry CS mets at diagnosis
2
514
515
Range check.
Range: 00-99
Leave blank if 10.3 = 1, 3
Collaborative stage (CS) mets at
diagnosis [NAACCR data item
#2850] obtained from the central
cancer registry database.
Valid values for CS mets at diagnosis include: 00, 08, 10, 40, 50, 99.
A complete list of valid values/labels will be provided for reference in the
CCDE User’s Manual.
See CS Staging Manual (pg 275):
http://www.cancerstaging.org/cstage/csman
ualpart2.pdf
Reserved for future use
CCDE Version 1.01
10
516
525
Leave blank.
C-56
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
Codes / Format / Comments
End
Edit Checks / Skip Patterns
11. Treatment Information - Complete this section when Final Diagnosis (9.2) = 2, 3 or 4
11.1
Status of treatment
1
526
526
In some cases, a polypectomy may
be considered both diagnostic and
treatment. In other cases surgery
may be considered both diagnostic
and start of treatment.
1 = Treatment started and/or completed
2 = Treatment pending
Ŧ
3 = Treatment not indicated
Ŧ
4 = Verbal/written refusal of treatment*
Ŧ
5 = Client moved
Ŧ
6 = Deceased
Ŧ
7 = Lost to follow-up*
9 = Unknown
Range check.
If “Final diagnosis” (9.2) = 2, 3, 4, then 11.1
must be completed.
*Programs must have a policy in place to define how much time can
elapse before the client is deemed refused or lost to follow-up.
Ŧ
These items should have an administrative close-out date reported in
11.2 “Date of treatment”.
11.2
Date of treatment
8
527
534
If just the year is known, blank fill the month and day. If just the year and
month are known, blank fill the day (e.g. 04 2006).
Can be the date treatment began,
when the client refused, or was
determined to be lost to follow-up.
Date that treatment began may be
the date of one of the tests. For
instance, if a polypectomy was done
and cancer was found and
removed, the date that the polyp(s)
was removed would also be the
date that treatment began.
11.3
Who paid for treatment?
CCDE Version 1.01
If 11.1 = 3-7, then an administrative closeout date will be necessary.
Leave blank if 11.1 = 2, 9
1
535
535
This is the primary source of
payment for treatment.
Reserved for future use
If 11.1 = 1, 3-7, then “MMDDYYYY”, “MM
YYYY” or “YYYY”.
MMDDYYYY
10
536
1 = Medicaid
2 = Other, State
3 = Medicare
4 = Self-Pay (by client)
5 = Charity care/uncompensated
6 = Other
9 = Unknown
545
Range check.
Leave blank if 11.1 ≠ 1 (Treatment started).
Leave blank.
C-57
April 26, 2006
Colorectal Cancer Clinical Data Elements (CCDEs)
Data Definition Table
Item
Variable Name
Column
Length
Begin
End
Codes / Format / Comments
Edit Checks / Skip Patterns
12. Record Information – Completed for each CCDE record
12.1
CCDE version
3
546
548
100 = For all data currently collected/reported
12.2
End of record mark
2
549
550
The record ends with a carriage return-line feed (CR-LF).
CCDE Version 1.01
C-58
Range check.
April 26, 2006
APPENDIX D
CDC RACE AND
ETHNICITY CODE SET
CDC Race and Ethnicity Code Set – Version 1.0 (03/2000)
Modified from original: http://www.cdc.gov/phin/vocabulary/race.html
TABLE 1 – RACE CONCEPTS AND CODES
MDE CATEGORY
CONCEPT
1. White
EUROPEAN (which may include:)
Armenian
English
French
German
Irish
Italian
Polish
Scottish
MIDDLE EASTERN OR NORTH AFRICAN (which
may include:)
Assyrian
Egyptian
Iranian
Iraqi
Lebanese
Palestinian
Syrian
Afghanistani
Israeli
ARAB
2. Black or African
American
Version 1.01
April 2006
BLACK
AFRICAN AMERICAN
AFRICAN (which may include:)
Botswanan
Ethiopian
Liberian
Namibian
Nigerian
Zairian
Bahamian
Barbadian
Dominican
Dominican Islander
Haitian
Jamaican
Chapter 2 – Appendix D
D-1
MDE CATEGORY
2. Black or African
American (cont’d)
3. Asian
4. Native Hawaiian or
Other Pacific Islander
D-2
CONCEPT
Tobagoan
Trinidadian
West Indian
Asian Indian
Bangladeshi
Bhutanese
Burmese
Cambodian
Chinese
Taiwanese
Filipino
Hmong
Indonesian
Japanese
Korean
Laotian
Malaysian
Okinawan
Pakistani
Sri Lankan
Thai
Vietnamese
Iwo Jiman
Maldivian
Nepalese
Singaporean
Madagascar
POLYNESIAN (which may include:)
Native Hawaiian
Samoan
Tahitian
Tongan
Tokelauan
MICRONESIAN (which may include:)
Guamanian
Chamorro
Mariana Islander
Marshallese
Palauan
Carolinian
Kosraean
Chapter 2 – Appendix D
Version 1.01
April 2006
MDE CATEGORY
4. Native Hawaiian or
Other Pacific Islander (Cont’d)
5. American Indian or
Alaskan Native
Version 1.01
April 2006
CONCEPT
Pohnpeian
Yapese
Saipanese
Kiribati
Chuukese
MELANESIAN (which may include:)
Fijian
Papua New Guinean
Solomon Islander
New Hebrides
OTHER PACIFIC ISLANDER
AMERICAN INDIAN
CANADIAN AND LATIN AMERICAN INDIAN (which
may include:)
Canadian Indian
Central American Indian
French American Indian
Mexican American Indian
South American Indian
Spanish American Indian
ALASKAN NATIVE (which may include:)
Alaskan Indian
Inuit
Aleut
Chapter 2 – Appendix D
D-3
CDC Race and Ethnicity Code Set – Version 1.0 (03/2000)
Modified from original: http://www.cdc.gov/phin/vocabulary/race.html
TABLE 2 – ETHNICITY CONCEPTS AND CODES
MDE CATEGORY
Hispanic or Latino
CONCEPT
Spaniard
Mexican
Central American
South American
Latin American
Puerto Rican
Cuban
Dominican
Not Hispanic or Latino
D-4
Chapter 2 – Appendix D
Version 1.01
April 2006
APPENDIX E
ADVERSE EVENTS
REPORTING FORM
This appendix is a placeholder for the Adverse Events Reporting Form
which can be located in the CRCSDP Policy Manual, Appendix 2.
APPENDIX F
CCDE Revision History
Appendix F
CCDE Revision History
Appendix F contains a detailed history of changes made to each of the variables that
comprise the Colorectal Cancer Clinical Data Elements (CCDEs). The CDC will regularly
assess the effectiveness of the CCDEs for the purposes of analysis, evaluation and
reporting to stakeholders; and changes will be made if necessary. The initial version of
the CCDEs, version 1.00, was finalized on February 6, 2006. The following tables list all
subsequent revisions to the CCDE variables in detail, grouped by CCDE version number,
and then listed in order by item number. The tables in this appendix correspond with the
revision history data provided for each item in the CCDE Field Descriptions.
CCDE Version 1.00:
Item number
02/06/2006
Details of modification to item
All CCDE items
CCDE Version 1.01:
Item number
Item 4.x
Item 5.x
Item 6.x.12
Item 7.xx.3.2
Item 7.xx.3.3
Item 9.1
Initial version / no revisions
04/26/2006
Details of modification to item
Revised to indicate that “This information can be self-reported by
the client, or can come from information documented in the
client’s medical record. Medical record information is preferred, if
available”
Revised to indicate that “This information can be self-reported by
the client, or can come from information documented in the
client’s medical record. Medical record information is preferred, if
available”
Revised skip pattern to include directions: Leave blank if 6.x.06 ≠
3, 4
Removed category 7 (Not biopsied or removed). This category
can only be used as the first procedure for removal (7.xx.3.1)
Removed category 7 (Not biopsied or removed). This category
can only be used as the first procedure for removal (7.xx.3.1)
Revised to indicate that categories 3 – 6 should have an
administrative close-out date reported in Item 9.3 (Date of
Diagnosis)
Item 9.5
Revised skip pattern to include directions: Leave blank if 9.1≠ 1.
Item 9.6
Revised skip pattern to include directions: Leave blank if 9.1≠ 1.
Item 11.1
Revised to indicate that categories 3 – 7 should have an
administrative close-out date reported in Item 11.2 (Date of
Treatment)
Version 1.01
April 2006
Chapter 2 – Appendix F
F-1
F-2
Chapter 2 - Appendix F
Version 1.01
April 2006
CHAPTER 3
Data Quality Assessment
Data Quality Assessment
The purpose of this chapter is to emphasize the importance of data quality and to
provide examples of how to plan for and assess data quality for this program. A
program needs to have computer software to assess data quality. The software used
will vary from program to program, but minimally a program should be able to monitor
the frequencies of important program variables. A program should have this software
available from the start of the program and someone should be designated to assess
data quality on an ongoing basis.
It is also very important for your program to have detailed documentation of your
computer software system and data quality assessment tools. This is essential in cases
of staff turnover or staff absence. This documentation, along with cross-training, will
allow the program to continually monitor the quality of the data.
The CDC is currently developing the data quality assessment tools that will be used to
monitor and evaluate the CRCSDP data. Therefore, no reports are currently included in
this chapter of the Data User’s Manual. Updated information for this chapter will be
provided in the future.
Version 1.01
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Chapter 3 – Data Quality Assessment
157
158
Chapter 3 – Data Quality Assessment
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April 2006
CHAPTER 4
Registry Linkage
Registry Linkage
Included in this chapter are tables from the SEER Program Coding and Staging Manual
2004 (http://seer.cancer.gov/tools/codingmanuals/); and the Collaborative Staging
Manual and Coding Instructions, version 1.0, jointly published by the American Joint
Committee on Cancer (AJCC) and the U.S. Department of Health and Human Services
(DHHS) (http://www.cancerstaging.org/cstage/manuals.html).
These cancer staging manuals provide detailed descriptions for the following items in
the CCDEs. These tables should be referenced in order to ensure accurate reporting of
these variables and their values:
•
•
•
•
•
•
CCDE Item 10.4: Registry primary site
CCDE Item 10.5: Registry CS-derived SS2000
CCDE Item 10.6: Registry CS-derived AJCC stage group
CCDE Item 10.7: Registry CS extension
CCDE Item 10.8: Registry CS lymph nodes
CCDE Item 10.9: Registry CS mets at diagnosis
In addition, the CDC is currently developing a linkage protocol for this chapter which will
contain valuable information to assist programs in the successful linkage of CCDEs with
their state cancer registry data. Updated information for this chapter will be provided in
the future.
Version 1.01
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Chapter 4 – Registry Linkage
159
160
Chapter 4 – Registry Linkage
Version 1.01
April 2006
Registry Linkage
CCDE Item 10.4: Registry primary site
Primary site [NAACCR data item #400] obtained from the central cancer registry
database. See the SEER Program Coding and Staging Manual (pg 73) at
http://seer.cancer.gov/manuals/SPM2004.pdf
C000 = External upper lip
C001 = External lower lip
C002 = External lip, NOS
C003 = Mucosa of upper lip
C004 = Mucosa of lower lip
C005 = Mucosa of lip, NOS
C006 = Commissure of lip
C008 = Overlapping lesion of lip
C009 = Lip, NOS
C019 = Base of tongue, NOS
C020 = Dorsal surface of tongue, NOS
C021 = Border of tongue
C022 = Ventral surface of tongue, NOS
C023 = Anterior 2/3 of tongue, NOS
C024 = Lingual tonsil
C028 = Overlapping lesion of tongue
C029 = Tongue, NOS
C030 = Upper gum
C031 = Lower gum
C039 = Gum, NOS
C040 = Anterior floor of mouth
C041 = Lateral floor of mouth
C048 = Overlapping of floor of mouth
C049 = Floor of mouth, NOS
C050 = Hard palate
C051 = Soft palate, NOS
C052 = Uvula
C058 = Overlapping lesion of palate
C059 = Palate, NOS
C060 = Cheek mucosa
C061 = Vestibule of mouth
C062 = Retromolar area
C068 = Overlapping of other mouth
C069 = Mouth, NOS
C079 = Parotid gland
C080 = Submandibular gland
C081 = Sublingual gland
Version 1.01
April 2006
C088 = Overlapping maj salivary glands
C089 = Major salivary gland, NOS
C090 = Tonsillar fossa
C091 = Tonsillar pillar
C098 = Overlapping lesion of tonsil
C099 = Tonsil, NOS
C100 = Vallecula
C101 = Anterior surface of epiglottis
C102 = Lateral wall of oropharynx
C103 = Posterior wall of oropharynx
C104 = Branchial cleft
C108 = Overlapping of oropharynx
C109 = Oropharynx, NOS
C110 = Superior wall of nasopharynx
C111 = Posterior wall of nasopharynx
C112 = Lateral wall of nasopharynx
C113 = Anterior wall of nasopharynx
C118 = Overlapping of nasopharynx
C119 = Nasopharynx, NOS
C129 = Pyriform sinus
C130 = Postcricoid region
C131 = Aryepiglottic fold, hypophar.
C132 = Posterior wall of hypopharynx
C138 = Overlapping of hypopharynx
C139 = Hypopharynx, NOS
C140 = Pharynx, NOS
C142 = Waldeyer's ring
C148 = Overlap of pharynx, etc.
C150 = Cervical esophagus
C151 = Thoracic esophagus
C152 = Abdominal esophagus
C153 = Upper third of esophagus
C154 = Middle third of esophagus
C155 = Lower third of esophagus
C158 = Overlapping lesion of esophagus
C159 = Esophagus, NOS
C160 = Cardia, NOS
Chapter 4 – Registry Linkage
161
Registry Linkage
C161 = Fundus of stomach
C162 = Body of stomach
C163 = Gastric antrum
C164 = Pylorus
C165 = Lesser curvature stomach NOS
C166 = Greater curvature stomach NOS
C168 = Overlapping lesion of stomach
C169 = Stomach, NOS
C170 = Duodenum
C171 = Jejunum
C172 = Ileum
C173 = Meckel's diverticulum
C178 = Overlapping of small intestine
C179 = Small intestine, NOS
C180 = Cecum
C181 = Appendix
C182 = Ascending colon
C183 = Hepatic flexure of colon
C184 = Transverse colon
C185 = Splenic flexure of colon
C186 = Descending colon
C187 = Sigmoid colon
C188 = Overlapping of colon
C189 = Colon, NOS
C199 = Rectosigmoid junction
C209 = Rectum, NOS
C210 = Anus, NOS
C211 = Anal canal
C212 = Cloacogenic zone
C218 = Overlap of rectum, anus, etc.
C220 = Liver
C221 = Intrahepatic bile duct
C239 = Gallbladder
C240 = Extrahepatic bile duct
C241 = Ampulla of Vater
C248 = Overlapping of biliary tract
C249 = Biliary tract, NOS
C250 = Head of pancreas
C251 = Body of pancreas
C252 = Tail of pancreas
C253 = Pancreatic duct
C254 = Islets of Langerhans
C257 = Other spec pancreas
C258 = Overlapping of pancreas
C259 = Pancreas, NOS
C260 = Intestinal tract, NOS
162
C268 = Overlapping of digestive system
C269 = Gastrointestinal tract, NOS
C300 = Nasal cavity
C301 = Middle ear
C310 = Maxillary sinus
C311 = Ethmoid sinus
C312 = Frontal sinus
C313 = Sphenoid sinus
C318 = Overlap of accessory sinuses
C319 = Accessory sinus, NOS
C320 = Glottis
C321 = Supraglottis
C322 = Subglottis
C323 = Laryngeal cartilage
C328 = Overlapping of larynx
C329 = Larynx, NOS
C339 = Trachea
C340 = Main bronchus
C341 = Upper lobe, lung
C342 = Middle lobe, lung
C343 = Lower lobe, lung
C348 = Overlapping of lung
C349 = Lung, NOS
C379 = Thymus
C380 = Heart
C381 = Anterior mediastinum
C382 = Posterior mediastinum
C383 = Mediastinum, NOS
C384 = Pleura, NOS
C388 = Ovr. heart, mediastinum, pleura
C390 = Upper respiratory tract, NOS
C398 = Overlap of respiratory system
C399 = Ill-defined sites of resp sys
C400 = Long bones: upper limb, scapula
C401 = Short bones: upper limb
C402 = Long bones: lower limb
C403 = Short bones: lower limb
C408 = Overlap of bones, etc. of limbs
C409 = Bone of limb, NOS
C410 = Bones of skull and face
C411 = Mandible
C412 = Vertebral column
C413 = Rib, Sternum, Clavicle
C414 = Pelvic bones, Sacrum, Coccyx
C418 = Overlap bones, etc.
C419 = Bone, NOS
Chapter 4 – Registry Linkage
Version 1.01
April 2006
Registry Linkage
C420 = Blood
C421 = Bone marrow
C422 = Spleen
C423 = Reticuloendothelial system, NOS
C424 = Hematopoietic system, NOS
C440 = Skin of lip, NOS
C441 = Eyelid
C442 = External ear
C443 = Skin other/unspec parts of face
C444 = Skin of scalp and neck
C445 = Skin of trunk
C446 = Skin of upper limb and shoulder
C447 = Skin of lower limb and hip
C448 = Overlapping of skin
C449 = Skin, NOS
C470 = Periph nerves: head, face, neck
C471 = Peri nerves: upr limb, shoulder
C472 = Periph nerves: lower limb, hip
C473 = Periph nerves: thorax
C474 = Periph nerves: abdomen
C475 = Periph nerves: pelvis
C476 = Periph nerves: trunk, NOS
C478 = Overlap of peripheral nerves
C479 = Autonomic nervous system, NOS
C480 = Retroperitoneum
C481 = Specified parts of peritoneum
C482 = Peritoneum, NOS
C488 = Overlap retroper & peritoneum
C490 = Conn tissues: head, face, neck
C491 = Conn tissues: upr limb, shoulder
C492 = Conn tissues: lower limb, hip
C493 = Conn tissues: thorax
C494 = Conn tissues: abdomen
C495 = Conn tissues: pelvis
C496 = Conn tissues: trunk, NOS
C498 = Overlapping conn tissues
C499 = Conn tissues, NOS
C500 = Nipple
C501 = Central portion of breast
C502 = Upper-inner quadrant of breast
C503 = Lower-inner quadrant of breast
C504 = Upper-outer quadrant of breast
C505 = Lower-outer quadrant of breast
C506 = Axillary tail of breast
C508 = Overlapping of breast
C509 = Breast, NOS
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April 2006
C510 = Labium majus
C511 = Labium minus
C512 = Clitoris
C518 = Overlapping of vulva
C519 = Vulva, NOS
C529 = Vagina, NOS
C530 = Endocervix
C531 = Exocervix
C538 = Overlapping of cervix uteri
C539 = Cervix uteri
C540 = Isthmus uteri
C541 = Endometrium
C542 = Myometrium
C543 = Fundus uteri
C548 = Overlapping of corpus uteri
C549 = Corpus uteri
C559 = Uterus, NOS
C569 = Ovary
C570 = Fallopian tube
C571 = Broad ligament
C572 = Round ligament
C573 = Parametrium
C574 = Uterine adnexa
C577 = Other spec fem genital organs
C578 = Overlap of fem genital organs
C579 = Female genital tract, NOS
C589 = Placenta
C600 = Prepuce
C601 = Glans penis
C602 = Body of penis
C608 = Overlapping of penis
C609 = Penis, NOS
C619 = Prostate gland
C620 = Undescended testis
C621 = Descended testis
C629 = Testis, NOS
C630 = Epididymis
C631 = Spermatic cord
C632 = Scrotum, NOS
C637 = Other spec male genital organs
C638 = Overlap male genital organs
C639 = Male genital organs, NOS
C649 = Kidney, NOS
C659 = Renal pelvis
C669 = Ureter
C670 = Trigone of bladder
Chapter 4 – Registry Linkage
163
Registry Linkage
C671 = Dome of bladder
C672 = Lateral wall of bladder
C673 = Anterior wall of bladder
C674 = Posterior wall of bladder
C675 = Bladder neck
C676 = Ureteric orifice
C677 = Urachus
C678 = Overlapping of bladder
C679 = Bladder, NOS
C680 = Urethra
C681 = Paraurethral gland
C688 = Overlapping of urinary organs
C689 = Urinary system, NOS
C690 = Conjunctiva
C691 = Cornea, NOS
C692 = Retina
C693 = Choroid
C694 = Ciliary body
C695 = Lacrimal gland
C696 = Orbit, NOS
C698 = Overlapping of eye and adnexa
C699 = Eye, NOS
C700 = Cerebral meninges
C701 = Spinal meninges
C709 = Meninges, NOS
C710 = Cerebrum
C711 = Frontal lobe
C712 = Temporal lobe
C713 = Parietal lobe
C714 = Occipital lobe
C715 = Ventricle, NOS
C716 = Cerebellum, NOS
C717 = Brain stem
C718 = Overlapping of brain
C719 = Brain, NOS
C720 = Spinal cord
C721 = Cauda equina
C722 = Olfactory nerve
C723 = Optic nerve
C724 = Acoustic nerve
C725 = Cranial nerve, NOS
C728 = Overlap of brain & cns
C729 = Nervous system, NOS
C739 = Thyroid gland
C740 = Cortex of adrenal gland
C741 = Medulla of adrenal gland
164
C749 = Adrenal gland, NOS
C750 = Parathyroid gland
C751 = Pituitary gland
C752 = Craniopharyngeal duct
C753 = Pineal gland
C754 = Carotid body
C755 = Aortic body & other paraganglia
C758 = Overlapping of endocrine glands
C759 = Endocrine gland, NOS
C760 = Head, face or neck, NOS
C761 = Thorax, NOS
C762 = Abdomen, NOS
C763 = Pelvis, NOS
C764 = Upper limb, NOS
C765 = Lower limb, NOS
C767 = Other ill-defined sites
C768 = Overlap of ill-defined sites
C770 = Lymph nodes: head, face & neck
C771 = Intrathoracic lymph nodes
C772 = Intra-abdominal lymph nodes
C773 = Lymph nodes of axilla or arm
C774 = Lymph nodes:inguinal region or leg
C775 = Pelvic lymph nodes
C778 = Lymph nodes of multiple regions
C779 = Lymph node, NOS
C809 = Unknown primary site
Chapter 4 – Registry Linkage
Version 1.01
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Registry Linkage
CCDE Item 10.5: Registry CS-derived SS2000
Collaborative stage (CS)-derived summary stage 2001 [NAACCR data item #3020]
obtained from the central cancer registry database. See CS Staging Manual (pg 67) at
http://www.cancerstaging.org/cstage/csmanualpart1.pdf and the SEER Summary Staging
Manual at http://seer.cancer.gov/tools/ssm/.
Value
Version 1.01
April 2006
Description
0
In situ
1
Localized
2
Regional, direct extension
3
Regional, lymph nodes only
4
Regional, extension and nodes
5
Regional, NOS
7
Distant
8
Not applicable
9
Unknown/unstaged
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166
Chapter 4 – Registry Linkage
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Registry Linkage
CCDE Item 10.6: Registry CS-derived AJCC stage group
Collaborative stage (CS)-derived AJCC stage [NAACCR data item #3000] obtained from the central cancer registry
database WHEN AVAILABLE. See Collaborative stage (CS) Staging Manual (pg 65) at
http://www.cancerstaging.org/cstage/csmanualpart1.pdf.
Value
00
01
02
10
11
12
13
14
15
16
17
18
19
23
24
20
21
22
30
31
32
33
34
Description
Stage 0
Stage 0a
Stage 0is
Stage I
Stage I NOS
Stage IA
Stage IA1
Stage IA2
Stage IB
Stage IB1
Stage IB2
Stage IC
Stage IS
Stage ISA (lymphoma only)
Stage ISB (lymphoma only)
Stage IEA (lymphoma only)
Stage IEB (lymphoma only)
Stage IE (lymphoma only)
Stage II
Stage II NOS
Stage IIA
Stage IIB
Stage IIC
Version 1.01
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Value
35
36
37
38
39
40
41
42
43
50
51
52
53
54
55
56
57
58
59
60
61
62
63
Description
Stage IIEA (lymphoma only)
Stage IIEB (lymphoma only)
Stage IIE (lymphoma only)
Stage IISA (lymphoma only)
Stage IISB (lymphoma only)
Stage IIS (lymphoma only)
Stage IIESA (lymphoma only)
Stage IESB (lymphoma only)
Stage IIES (lymphoma only)
Stage III
Stage III NOS
Stage IIIA
Stage IIIB
Stage IIIC
Stage IIIEA (lymphoma only)
Stage IIIEB (lymphoma only)
Stage IIIE (lymphoma only)
Stage IIISA (lymphoma only)
Stage IIISB (lymphoma only)
Stage IIIS (lymphoma only)
Stage IIIESA (lymphoma only)
Stage IIIESB (lymphoma only)
Stage IIIES (lymphoma only)
Chapter 4 – Registry Linkage
Value
70
71
72
73
74
88
90
99
Description
Stage IV
Stage IV NOS
Stage IVA
Stage IVB
Stage IVC
Not applicable
Stage Occult
Stage Unknown
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168
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Registry Linkage
CCDE Item 10.7: Registry CS extension
Collaborative stage (CS) extension [NAACCR data item #2810] obtained from the central cancer registry database. See
CS Staging Manual (pg 272) at http://www.cancerstaging.org/cstage/csmanualpart2.pdf.
Value
Description for Colon
Description for Rectum
TNM
SS77
SS2000
00
In situ; noninvasive; intraepithelial
In situ; noninvasive; intraepithelial
Tis
IS
IS
05
(Adeno)carcinoma in a polyp or adenoma,
noninvasive
(Adeno)carcinoma in a polyp or adenoma,
noninvasive
Tis
IS
IS
10
Invasive tumor confined to mucosa, NOS,
including intramucosal, NOS
Invasive tumor confined to mucosa, NOS,
including intramucosal, NOS
Tis
L
L
11
Lamina propria, including lamina propria in the
stalk of a polyp
Lamina propria, including lamina propria in the
stalk of a polyp
Tis
L
L
12
Muscularis mucosae, including muscularis
mucosae in the stalk of a polyp
Muscularis mucosae, including muscularis
mucosae in the stalk of a polyp
T1
L
L
13
Confined to head of polyp, NOS
Confined to head of polyp, NOS
T1
L
L
14
Confined to stalk of polyp, NOS
Confined to stalk of polyp, NOS
T1
L
L
15
Invasive tumor in polyp, NOS
Invasive tumor in polyp, NOS
T1
L
L
16
Invades submucosa (superficial invasion),
including submucosa in the stalk of a polyp
Submucosa (superficial invasion), including
submucosa in the stalk of a polyp
T1
L
L
20
Muscularis propria invaded
Muscularis propria invaded
T2
L
L
30
Localized, NOS
Confined to colon, NOS
Localized, NOS
Confined to rectum, NOS
T1 (colon) /
Tx (rectum)
L
L
Version 1.01
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Chapter 4 – Registry Linkage
169
Registry Linkage
Value
Description for Colon
Description for Rectum
TNM
SS77
SS2000
40
Extension through wall, NOS
Invasion through muscularis propria or
muscularis, NOS
Non-peritonealized pericolic tissues invaded
Perimuscular tissue invaded
Subserosal tissue/(sub)serosal fat invaded
Transmural, NOS
Extension through wall, NOS
Invasion through muscularis propria or
muscularis, NOS
Perimuscular tissue invaded
Subserosal tissue/(sub)serosal fat invaded
Non-peritonealized pericolic tissues invaded
Transmural, NOS
T3
L
L
42
Fat, NOS
Fat, NOS
T3
RE
RE
45
Extension to:
All colon sites:
Adjacent tissue(s), NOS
Connective tissue
Mesenteric fat
Mesentery
Mesocolon
Pericolic fat
Ascending and descending colon
Retroperitoneal fat
Transverse colon/flexures
Gastrocolic ligament
Greater omentum
Adjacent (connective) tissue:
For all sites:
Perirectal fat
For rectosigmoid:
Mesentery (including mesenteric fat,
mesocolon)
Pericolic fat
For rectum:
Extension to anus
Rectovaginal septum
T3
RE
RE
46
Adherent to other organs or structures, but no
microscopic tumor found in adhesion(s)
Adherent to other organs or structures but no
tumor found in adhesion(s)
T3
RE
RE
50
Invasion of/through serosa (mesothelium)
(visceral peritoneum)
Invasion of/through serosa (mesothelium)
(visceral peritoneum)
T4
RE
RE
55
Any of [(42) to (45)] + (50)
(50) with [(42) or (45)]
T4
RE
RE
57
Adherent to other organs or structures, NOS
Adherent to other organs or structures, NOS
T4
RE
RE
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Registry Linkage
Value
Description for Colon
Description for Rectum
TNM
SS77
SS2000
T4
RE
RE
60
All colon sites:
Small intestine
Cecum and appendix:
Greater omentum
Ascending colon:
Greater omentum
Liver, right lobe
Tranverse colon and flexures:
Gallbladder/bile ducts
Kidney
Liver
Pancreas
Spleen
Stomach
Descending colon:
Greater omentum
Pelvic wall
Spleen
Sigmoid colon:
Greater omentum
Pelvic wall
65
All colon sites:
Abdominal wall
Retroperitoneum (excluding fat)
T4
RE
RE
66
Ascending colon:
Right kidney
Right ureter
Descending colon:
Left kidney
Left ureter
T4
RE
RE
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Rectosigmoid:
Cul de sac (rectouterine pouch)
Pelvic wall
Small intestine
Rectum:
Bladder for males only
Cul de sac (rectouterine pouch)
Ductus deferens
Pelvic wall
Prostate
Rectovesical fascia for male only
Seminal vesicle(s)
Skeletal muscle of pelvic floor
Vagina
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Registry Linkage
Value
Description for Colon
Description for Rectum
70
Cecum, appendix, ascending, descending and
sigmoid colon:
Fallopian tube
Ovary
Uterus
75
All colon sites unless otherwise stated above:
Adrenal (suprarenal) gland
Bladder
Diaphragm
Fistula to skin
Gallbladder
Other segment(s) of colon via serosa
80
Further contiguous extension:
Cecum and appendix:
Kidney
Liver
Ureter
Transverse colon and flexures:
Ureter
Sigmoid colon:
Cul de sac (rectouterine pouch)
Ureter
Other contiguous extension
172
Rectosigmoid:
Bladder
Colon via serosa
Fallopian tube(s)
Ovary(ies)
Prostate
Ureter(s)
Uterus
Rectum:
Bladder for female only
Bone(s) of pelvis
Urethra
Uterus
Further contiguous extension
Chapter 4 – Registry Linkage
TNM
SS77
SS2000
T4
D
D
T4
D
D
T4
D
D
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Registry Linkage
Value
Description for Colon
Description for Rectum
TNM
SS77
SS2000
95
No evidence of primary tumor
No evidence of primary tumor
T0
U
U
99
Unknown extension
Primary tumor cannot be assessed
Not documented in patient record
Unknown extension
Primary tumor cannot be assessed
Not documented in patient record
TX
U
U
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Registry Linkage
CCDE Item 10.8: Registry CS lymph nodes
Collaborative stage (CS) lymph nodes [NAACCR data item #2830] obtained from the central cancer registry database.
See CS Staging Manual (page 274) at http://www.cancerstaging.org/cstage/csmanualpart2.pdf.
Value
Description for Colon
Description for Rectum
TNM
SS77
SS2000
00
None; no regional lymph node involvement
None; no regional lymph node involvement
N0
None
None
10
Regional lymph node(s) for all colon sites:
Colic (NOS)
Epicolic (adjacent to bowel wall)
Mesocolic (NOS)
Paracolic/pericolic
Nodule(s) or foci in pericolic fat/adjacent
mesentery/mesocolic fat
Regional lymph node(s):
Rectosigmoid:
Paracolic/pericolic
Perirectal
Rectal
Nodule(s) or foci in pericolic fat/adjacent
mesentery/mesocolic fat
Rectum:
Perirectal
Rectal, NOS
Nodule(s) or foci in perirectal fat
*
RN
RN
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Registry Linkage
Value
Description for Colon
Description for Rectum
TNM
SS77
SS2000
20
Regional lymph node(s), for specific subsites:
Cecum and appendix:
Cecal: anterior (prececal), posterior
(retrocecal); NOS
Ileocolic
Right colic
Ascending colon:
Ileocolic
Middle colic
Right colic
Transverse colon and flexures:
Inferior mesenteric for splenic flexure only
Left colic for splenic flexure only
Middle colic
Right colic for hepatic flexure only
Descending colon:
Inferior mesenteric
Left colic
Sigmoid
Sigmoid colon:
Inferior mesenteric
Sigmoidal (sigmoid mesenteric)
Superior hemorrhoidal
Superior rectal
Regional lymph node(s):
Rectosigmoid:
Colic, NOS
Left colic
Hemorrhoidal, superior or middle
Inferior mesenteric
Middle rectal
Sigmoidal (sigmoid mesenteric)
Superior rectal
Rectum:
Hemorrhoidal, superior, middle or inferior
Inferior mesenteric
Internal iliac (hypogastric)
Obturator
Rectal, superior, middle, or inferior
Sacral, NOS
Lateral (laterosacral)
Middle (promontorial) (Gerota's node)
Presacral
Sacral promotory
Sigmoidal (sigmoid mesenteric)
*
RN
RN
30
Regional lymph node(s) for all colon sites:
Mesenteric, NOS
Regional lymph node(s), NOS
Mesenteric, NOS
Regional lymph node(s), NOS
*
RN
RN
80
Lymph nodes, NOS
Lymph nodes, NOS
*
RN
RN
99
Unknown; not stated
Regional lymph node(s) cannot be assessed
Not documented in patient record
Unknown; not stated
Regional lymph node(s) cannot be assessed
Not documented in patient record
NX
U
U
* For codes 10-80 ONLY, the N category is assigned based on the value of Reg LN Pos, using the Lymph Nodes Number
Positive Table for this site.
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CCDE Item 10.9: Registry CS mets at diagnosis
Collaborative stage (CS) metastases (mets) at diagnosis obtained from the central cancer registry database. North
American Association of Central Cancer Registries (NAACCR) data item #2850. See the CS Staging Manual (page 275)
at http://www.cancerstaging.org/cstage/csmanualpart2.pdf.
Value
Description for Colon
00
No; none
08
Cecum, appendix, ascending, hepatic flexure
and transverse colon:
Superior mesenteric lymph node(s)
10
Distant lymph node(s) other than code 08
For all colon sites:
Common iliac
Distant lymph node(s), NOS
External iliac
Para-aortic
Retroperitoneal
For cecum, appendix, ascending colon,
transverse colon, and hepatic flexure:
Inferior mesenteric
For splenic flexure, descending colon, and
sigmoid colon:
Superior mesenteric
11
12
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Description for Rectum
TNM
SS77
SS2000
M0
None
None
M1
RN
D
Distant lymph node(s), NOS
M1
D
D
Rectosigmoid:
Internal iliac (hypogastric)
Obturator
M1
RN
D
Other distant lymph node(s), including
external iliac or common iliac
M1
D
D
No; none
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177
Registry Linkage
Value
40
50
99
178
Description for Colon
Distant metastases except distant lymph
node(s) (codes 08-10)
Distant metastasis, NOS
Carcinomatosis
(40) + [(08) or (10)]
Distant lymph node(s) plus other distant
metastases
Unknown if distant metastasis
Distant metastasis cannot be assessed
Not documented in patient record
Description for Rectum
Distant metastases except distant lymph
node(s) codes 10-12
Distant metastasis, NOS
Carcinomatosis
(40) + any of [(10) to (12)]
Distant lymph node(s) plus other distant
metastases
Unknown if distant metastasis
Distant metastasis cannot be assessed
Not documented in patient record
Chapter 4 – Registry Linkage
TNM
SS77
SS2000
M1
D
D
M1
D
D
MX
U
U
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CHAPTER 5
Communications
Communications
The purpose of this chapter is to provide a central location to store information provided
to the program from the CDC. This chapter can be used as a placeholder for memos
from the CDC and IMS regarding the CCDE data and their submission. While these
memos will continue to be announced and stored on the www.crcsdp.org Web site,
hardcopies may be placed here for quick reference.
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180
Chapter 5 – Communications
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CHAPTER 6
Meeting Minutes
Meeting Minutes
This chapter can be used as a placeholder for meeting minutes distributed by the CDC
and IMS regarding the CCDE data and their submission. While these memos will
continue to be announced and stored on the www.crcsdp.org Web site, hardcopies may
be placed here for quick reference.
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CHAPTER 7
References
References
This chapter contains a list of optional reading material related to colorectal cancer
screening. These items will be listed in a bibliography type format. In addition, it will
include definitions for common abbreviations used by this demonstration program.
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References
ACS:
http://www.cancer.org
Adenomatous polyp
See “Polyp”. More likely to develop into cancer than a
non-adenomatous polyp. Also known as “adenoma”.
CDC CRCSDP Home Page:
http://www.cdc.gov/colorectalcancer/
Colonoscope:
A flexible, lighted instrument with a built-in tiny camera
used to view the inside of the entire colon and rectum.
Colonoscopy:
An examination in which the doctor looks at the
internal walls of the entire colon through a flexible,
lighted instrument called a colonoscope. The doctor
may collect samples of tissue or cells for closer
examination. The doctor may also remove polyps
during colonoscopy.
Colorectal:
Related to the colon, rectum or both.
CRCSDP Awardee Contacts:
https://www.crcsdp.org/main/all_contacts
CRCSDP Resource Web Site:
www.crcsdp.org
CS Coding Manual:
http://www.cancerstaging.org/cstage/manuals.html
Double-Contrast Barium
Enema
A series of x-rays of the colon and rectum. The x-rays
are taken after the patient is given an enema, followed
by an injection of air. The barium outlines the
intestines on the x-rays, allowing many abnormal
growths to be visible.
Fecal Immunochemical Test
(FIT)
Like a fecal occult blood test (FOBT), an FIT also
detects hidden blood in the stool using a different
technique than guaiac based FOBT. FIT is effectively
done the same way as an FOBT, but it may be more
specific or more sensitive than a guaiac based FOBT.
Fecal Occult Blood Test
(FOBT)
A test to check for hidden blood in stool. Fecal refers
to stool. Occult means hidden. Sometimes called
"F.O.B.T.".
Flexible Sigmoidoscopy
A procedure in which the doctor looks inside the
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References
rectum and the lower portion of the colon (sigmoid
colon) through a flexible, lighted tube called a
sigmoidoscope. The doctor may collect samples of
tissue or cells for closer examination and remove
some polyps within view.
Gastroenterologist
A doctor who specializes in diagnosing and treating
disorders of the digestive system (which includes the
esophagus, stomach, pancreas, intestines, and liver).
Polyp
An abnormal, often precancerous growth of tissue
(colorectal polyps are growths of tissue inside the
intestine).
Rectum
The last 8 to 10 inches of the large intestine. The
rectum stores solid waste until it leaves the body
through the anus.
Screening Test
"Screening tests" are tests used to check, or screen,
for disease when there are no symptoms. Screening
tests for colorectal cancer include: fecal occult blood
test, flexible sigmoidoscopy, colonoscopy, and double
contrast barium enema. (When a test is performed to
find out why symptoms exist, it is called a "diagnostic"
test).
SEER Coding Manual:
http://seer.cancer.gov/tools/codingmanuals
Sigmoidoscope
A flexible, lighted instrument with a built-in tiny camera
that allows the doctor to view the lining of the rectum
and lower portion of the colon.
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| File Type | application/pdf |
| File Title | ITEM NO / NAME: |
| Author | Mattingl |
| File Modified | 2006-05-12 |
| File Created | 2006-05-12 |