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

National Cancer Institute (NCI)

Status: Completed

Conditions: Immunocompromised Host; Organ Transplantation; Cancer

Study type: Observational

Funder types: NIH

Identifiers

NCT00904579

999906194

06-C-N194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19,929,901 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

19,929,901 participants in 1 patient group

1

Description:

Cancer patients who have had organ transplants identified through the transplant and cancer registries.