Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease

Study Overview
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Brief Summary
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Background: Solid organ transplantation provides life-saving treatment for end-stage organ disease but is associated with an increased cancer risk because of the need for long-term immunosuppression End-stage renal disease (ESRD), the most common type of end-stage organ disease leading to transplant, is itself linked to increased risk for some cancers The role of immunosuppression and other factors causing cancer in this setting are not fully understood. Objectives: To characterize cancer risk in transplant recipients and identify risk factors. To characterize risk for transmission of cancer from organ donors to recipients. To describe cancer risk in ESRD. Eligibility: Patients are not required for this study. Data are gathered from existing databases of ESRD patients, organ transplant patients and cancer registries. Design: Databases of 1) U.S. transplant recipients, donors and wait list candidates and 2) U.S. ESRD patients will be linked to multiple U.S. cancer registries to identify cancers in transplant recipients and ESRD patients. The spectrum of cancer risk in transplant recipients and ESRD patients will be evaluated in detail. The cancer risk in transplant recipients will be examined in relation to whether the donors had cancer. The proposed cancer risk factors (e.g., underlying medical condition, infection with cancer-causing viruses, immunosuppressive medications) documented in transplant and ESRD files will be studied for association with increased risk of particular types of cancer.

Detailed Description
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Solid organ transplantation provides life-saving treatment for end-stage organ disease but is associated with substantially elevated cancer risk, largely due to the need to maintain long-term immunosuppression. Despite previous research, important research questions remain concerning the role of immunosuppression and other factors in causing cancer in the setting. Staff at two federal agencies, the National Cancer Institute (NCI) and the Health Resources and Services Administration (HRSA), will link a database containing information on U.S. transplant recipients, wait list candidates, and donors to multiple U.S. cancer registries. These data will be used to conduct research concerning the spectrum of cancer risk in transplant recipients. The data will also be used by HRSA in its public health role overseeing the U.S. solid organ transplant network to maintain and improve safety of organ transplantation.

Official Title
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Cancer Risk in Solid Organ Transplant Recipients and End-Stage Renal Disease: The Transplant Cancer Match Study

Conditions
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Immunocompromised Host, Organ Transplantation, Cancer

Participation Criteria
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Eligibility Criteria
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This study will include as subjects all individuals included in the transplant data set. All U.S. solid organ transplant recipients, candidates for transplant, and living related donors. In addition, the study will include all individuals in the U.S. ESRD data set.

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Cancer patients who have had organ transplants identified through the transplant and cancer registries. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer | Cancer patients who have had organ transplants identified through the transplant and cancer registries. | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organ Transplants, Immunosuppression, Cancer, End Stage Renal Disease, ESRD, Cancer Risk