Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease
Conditions
Immunocompromised Host - Organ Transplantation - Cancer
Conditions: official terms
Kidney Failure, Chronic
Conditions: Keywords
Organ Transplants, Immunosuppression, Cancer, End Stage Renal Disease, ESRD, Cancer Risk
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Retrospective
Overall Status
Recruiting
Summary
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
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. The investigators propose linking a database of U.S. transplant recipients (458,834 transplants, 1987-June 2010), donors, and wait list candidates, and to multiple U.S. cancer registries. This linkage will allow identification of incident cancers in transplant recipients. Using these data, investigators will conduct a detailed evaluation of the spectrum of cancer risk in transplant recipients. Additionally, the investigators will examine cancer risk in transplant recipients in relation to whether donors themselves had cancer, to study possible donor-to-recipient transmission of cancer. The investigators will also study whether proposed cancer risk factors (e.g., underlying medical condition, infection with oncogenic viruses, immunosuppressive medications), documented in transplant files, are associated with increased risk of particular types of cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: - 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.
Location
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States
Status: Recruiting
Contact: Eric Engels, M.D. - 301-435-4722 - engelse@exchange.nih.gov
Start Date
June 2006
Sponsors
National Cancer Institute (NCI)
Source
National Institutes of Health Clinical Center (CC)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page