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Intestine Post Transplant Maligancy_Instructions
ICR 202506-0915-004 · OMB 0915-0157 · Object 159256301.
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
|---|---|
| File Title | Intestine Post Transplant Maligancy_Instructions |
| Author | Tara Taylor |
| Last Modified By | Writer |
| File Modified | 2024-11-20 |
| File Created | 2026-09-14 |
| Conversion State | complete |
Extracted Text
Intestine Post Transplant Malignancy The Post-Transplant Malignancy (PTM) record is generated after a malignancy has been reported in the Transplant Recipient Follow-up (TRF) record. The record should be completed by the transplant center responsible for the follow-up of the recipient at the time the cancer was reported. If the patient has more than one follow-up record because of a multi-organ transplant, the malignancy only needs to be reported in one of the follow-up records. If it is reported in more than one, only one PTM record will be generated. If Yes was selected for Post Transplant Malignancies, along with one or more of the post-transplant malignancies listed on the TRF record, the following sections will display in the Post-Transplant Malignancy record: Donor Related, Recurrence of Pretransplant Malignancy, Post Transplant De Novo Solid Tumor and/or Post Tx Lymphoproliferative Disease and Lymphoma. To change the section of the malignancy record that was generated, access the TRF record and select No to the section that is not needed, and select Yes to the section of the malignancy record that is needed. To delete the malignancy record, re-access the TRF record and select No in the Post Transplant Malignancies field. Note: If no information is available about the malignancy except the fact that they were treated, contact the UNetSM Help Desk at 1-800-978-4334. They will have the PTM record validated. The PTM must be completed within 30 days from the record generation date. See OPTN Policies for additional information. Use the search feature to locate specific policy information on Data Submission Requirements. To correct information that is already displayed in an electronic record, call the UNetSM Help Desk at 1-800-978-4334. Recipient Information The following fields reported in the recipient's last completed TRF record display. Recipient name: Verify the last name, first name and middle initial of the transplant recipient. Date of birth: Verify the recipient's date of birth. Recipient SSN: Verify the recipient's social security number. Recipient organ: Verify the type of organ transplanted. TRF: Verify the Transplant Recipient Follow-up record number from which this malignancy record was generated. Follow-up code: Verify the TRF Follow-up Code for the record from which this malignancy record was generated. Transplant date: Verify that the displayed transplant date is correct. The transplant date is determined by the beginning of organ anastomosis. For a multi-organ transplant procedure, the transplant date for each organ is determined by the transplant date of the first organ transplanted. Follow-up center: Verify that the follow-up center listed is responsible for the follow-up of the recipient at the time the cancer was reported. Recipient center: Verify that the transplant center listed is where the transplant procedure took place. Donor Related This section will only display if Yes was selected for Donor Related on post transplant malignancies listed in the TRF record. In most instances the donor does not have a history of cancer and transmission of cancer is unexpected. This occurrence is usually discovered when multiple recipients of organs from a single donor develop the same cancer (e.g. Melanoma). It may also occur when the clinical (not histological) diagnosis of primary brain cancer is made when, in fact, the donor had a metastatic brain cancer from an occult (concealed from observation) primary site. Select one or more tumor types: Select all tumor types that apply to the patient by clicking on the checkbox next to the type. Diagnosis date: Enter the date of diagnosis using the standard 8-digit format of MM/DD/YYYY. The date must fall within the follow-up period and after the transplant date that is displayed. If the month and year for any date is known but the exact day is unknown, enter a 15 for the day (i.e. the middle of the month). This field is required. Treatment Information: Select the type of treatment used for this type of tumor by clicking on the checkbox beside the treatment type. Surgical resection tumor Chemotherapy: Select the type of treatment from the drop-down list. If Other, specify is selected, enter the name of the treatment in the Other specify field. (List of Chemotherapy codes) CHOP MACOP-B Pro-Mace-CytaBOM M-BACOD 5FU/Gemzar 5FU/Leucovorin 5FU/Leucovorin/CPT-11 5FU/Mitomycin ACDA Adriamycin Anedia Bleomycin/Cisplatin/Etoposide Carboplatin/Etoposide Carboplatin/Taxol/Gemcitabine Carboplatin/VP-16 Cisplatin/VP-16 Cyclophosphamide Cyclophosphamide/Prednisone Cytoxan Cytoxan/Adriamycin Cytoxan/Onkovin/Adriamycin/Prednisone DHAP Doxorubicin Doxorubicin/and/Streptozocin EPOCH Etoposide/Doxorubicin/Vincristine Etropralide/Ifosfamide Eulexin/Lupron Gemcitabine Leucovorin/Methotrexate Lupron Melphazan/Prednisone Methotrexate Mitomycin/Carboplatin Navelbine/Taxol Nilandron Tamoxifen Taxol/5FU/Carb Taxol/Adriamycin Taxol/Carboplatin Taxol/Carboplatin/Zofran Topotecan Vidarabine/Cisplatin/Dexamethasone Vincristine Vincristine/Prednisone VP16 VP16/Etoposide Carboplatin/Gemcitabine Other, specify Radiation Immunotherapy: Select the type of treatment from the drop-down list. If Other, specify is selected, enter the name of the treatment in the Other specify field. (List of Immunotherapy codes) Hormonal Therapy Interferon Alpha Prednisone Rituximab Other, specify Other Treatment Specify: Enter the name of any other tumor treatment that was given. Outcome: Select the outcome from the drop-down list. Alive, Free of Tumor Alive with Tumor Dead, due to tumor Dead, other causes Recurrence of Pretransplant Malignancy This section will only display if Yes was selected for Recurrence of Pretransplant Malignancy on post transplant malignancies listed in the TRF record. The patient has a past history of cancer, and develops the same type of cancer post-transplantation. This does not apply to basal cell or squamous cell carcinoma of the skin, unless it recurs in the original site. The patient has a cancer in an explanted (removed) organ (usually liver or maybe kidney), and later develops a recurrence of the same type of cancer. For example, the patient has a hepatocellular carcinoma of the native liver (hepatoma), which is resected at the time of transplantation, and develops a recurrent hepatocellular carcinoma (at any site, at any time). Type of pre-existing tumor: Select type of pre-existing tumor from the drop-down list. This field is required. Skin (Squamous, Basal Cell) Skin - Melanoma Genitourinary - Bladder Genitourinary - Uterine Cervix Genitourinary - Uterine Body (endometrial & choriocarcinoma) Genitourinary - Vulva Genitourinary - Ovarian Genitourinary - Testicular Genitourinary - Prostate Genitourinary - Kidney Gastrointestinal - Stomach Gastrointestinal - Small Intestine Gastrointestinal - Carcinoid Gastrointestinal - Colo-Rectal Gastrointestinal - Liver/Biliary Tract (incidental time of hepatectomy) Gastrointestinal - Liver/Biliary tract, not incidental Gastrointestinal - Pancreas Thyroid Breast Tongue/Mouth,Pharynx Larynx Lung (include bronchial) Leukemia Lymphoma Other Cancer, Specify If Other Cancer, Specify: Enter the type of pre-existing tumor in the Other specify field. Date of recurrence (post-tx): Enter the date, using the standard 8-digit format of MM/DD/YYYY, the cancer recurred. This date must be after the transplant date and fall within the follow-up period that is displayed. This field is required. Post Transplant De Novo Solid Tumor This section will only display if Yes was selected for Post Transplant De Novo Solid Tumor on post transplant malignancies listed in the TRF record. This includes all new malignant tumors except Post Transplant Lymphoproliferative Disease. This includes all skin cancers, sarcomas, adenocarcinomas, hematological malignancies, and many cancers with special names. It does not include benign tumors such as nevi, adenomas, or fibromas. Usually, the description should include the type of cancer (e.g. squamous cell, adenocarcinoma), and the organ involved. Select the one or more tumor types: Select all tumor types that apply to the patient by clicking on the checkbox next to the type. This field is required. Skin: If squamous cell, basal cell and/or melanoma skin tumors are selected, complete the following section: Sites: Select the site(s) affected by clicking on the checkbox next to the site. Single Multiple Site Location: Indicate the area by selecting Lips/Head/Neck, Extremities or Trunk. Spread: Indicate if the skin malignancy has spread by selecting None, Nodes and/or Other. If Other is selected, enter the location. # of occurrences: Enter the number of occurrences during the follow-up period. If the number of occurrences during the follow-up period is unavailable, select the reason from the status (ST) drop-down list (Missing, Unknown, N/A, Not Done). Kaposi's sarcoma: cutaneous Kaposi's sarcoma: visceral Brain: Select the specific type of brain tumor from the drop-down list. If Other Specify is selected, enter the type of tumor in the Other specify field. (List of Brain Tumor codes) Astrocytoma Medulloblastoma Glioblastoma Multiforme Neuroblastoma Meningioma, Malignant Meningioma, Benign Angioblastoma Other Specify Renal carcinoma - Specify Site(s): Enter the site(s) in the space provided. Carcinoma of vulva, perineum or penis, scrotum Carcinoma of uterus: Select the type of carcinoma from the drop-down list. (List of Uterine Carcinoma codes) Cervix, invasive Cervix, in situ Body, Endometrium Ovarian Testicular Esophagus Stomach Small intestine Pancreas Larynx Tongue, throat Thyroid Bladder Breast Prostate Metastatic Liver Tumor - Specify Original Site: Select the original site from the drop-down list. If Other is selected, enter the site in the Other specify field. (List of Metastatic Liver Tumor codes) Stomach Adenocarcinoma Colon Adenocarrcinoma Breast Carcinoma Pancreas Carcinoma Bronchial Carcinoma Carcinoid (Neuroendocrine) Other Lung (include bronchial): Indicate either Small Cell or Non-small Cell. Leukemia: Select the leukemia type from the drop-down list. (List of Leukemia codes) AML (acute myelocytic leukemia) ALL (acute lymphocytic leukemia) MDS (myelodysplasia syndrome) CML (chronic myelocytic leukemia) CLL (chronic lymphocytic leukemia) Other Sarcomas (excluding Kaposi's) Site(s): Enter the site(s). Specify type: Select the type of sarcoma from the drop-down list. If Other is selected, enter the type in the Other specify field. (List of Sarcoma codes) Fibrosarcoma Liposarcoma Leiomyosarcoma Rhabdomyosarcoma Angiosarcoma Malignant Hemangiopericytoma Neurofibrosarcoma Neuroblastoma Chondrosarcoma Osteosarcoma Ewing's sarcoma Other If Other Cancers is selected, enter the Site(s) and the type of cancer in the spaces provided (this field is required). Primary Unknown: Select if the type of tumor is unknown. The Treatment Information must be completed when a type of tumor is selected from the Post Transplant De Novo Solid Tumor section of the record. All applicable fields must be completed. Post Transplant Lymphoproliferative Disease and Lymphoma This section will only display if Yes was selected for Post TX Lymphoproliferative Disease and Lymphoma on post transplant malignancies listed in the TRF record. Lymphoid growths that occur in organ transplant patients, in which evidence of Epstein-Barr virus (EBV) can be demonstrated; a family of lesions that straddle the border between infection and neoplasia (tumors). The spectrum runs from infectious mononucleosis to clonal proliferation of lymphoid cells to gross tumor formation and malignancy. PTLDs must be distinguished from sporadic lymphomas or non-EBV-associated lymphadenopathies, which may also be seen in the transplant population. Diagnosis date: Enter the date using the standard 8-digit format of MM/DD/YYYY. The date must fall within the follow-up period and after the transplant. This field is required. Pathology: Select the pathology of the disease from the drop-down list. This field is required. If Other, Specify is selected, enter the disease in the Other Specify field. (List of Pathology codes) Polymorphic Hyperplasia Polymorphic PTLD(lymphoma) Monomorphic PTLD(lymphoma) Multiple Myeloma, Plasmacytoma Hodgkin's Disease Other, Specify Public Burden Statement: The private, non-profit Organ Procurement and Transplantation Network (OPTN) collects this information in order to perform the following OPTN functions: to assess whether applicants meet OPTN Bylaw requirements for membership in the OPTN; and to monitor compliance of member organizations with OPTN Obligations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0915-0157 and it is valid until XX/XX/202X. This information collection is required to obtain or retain a benefit per 42 CFR §121.11(b)(2). All data collected will be subject to Privacy Act protection (Privacy Act System of Records #09-15-0055). Data collected by the private non-profit OPTN also are well protected by a number of the Contractor’s security features. The Contractor’s security system meets or exceeds the requirements as prescribed by OMB Circular A-130, Appendix III, Security of Federal Automated Information Systems, and the Departments Automated Information Systems Security Program Handbook. The public reporting burden for this collection of information is estimated to average 0.27 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Information Collection Clearance Officer, 5600 Fishers Lane, Room 14N39, Rockville, Maryland, 20857 or [email protected].