Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease
- Conditions
- Organ TransplantationImmunocompromised HostCancer
- Registration Number
- NCT00904579
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19929901
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cancer End of study Cancer patients who have had organ transplants identified through the transplant and cancer registries.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
California Cancer Registry
🇺🇸Sacramento, California, United States
Colorado Cancer Registry
🇺🇸Denver, Colorado, United States
Connecticut Cancer Registry
🇺🇸Hartford, Connecticut, United States
Iowa Cancer Registry
🇺🇸Iowa City, Iowa, United States
Georgia Cancer Registry
🇺🇸Atlanta, Georgia, United States
New Jersey Cancer Registry
🇺🇸New Brunswick, New Jersey, United States
National Cancer Institute (NCI), 9000 Rockville Pike
🇺🇸Bethesda, Maryland, United States
Seattle Cancer Registry
🇺🇸Seattle, Washington, United States
New York Cancer Registry
🇺🇸Albany, New York, United States