Clinical trial NCT00904579: Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease
Official title: Cancer Risk in Solid Organ Transplant Recipients and End-Stage Renal Disease: The Transplant Cancer Match Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunocompromised Host
Organ Transplantation
Cancer
Keywords: Organ Transplants
Immunosuppression
Cancer
End Stage Renal Disease
ESRD
Cancer Risk
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2009-05-19
Enrollment: 19929901
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients who have had organ transplants identified through the transplant and cancer registries.@@@

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.

Eligibility 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.

Primary outcomes:
measure: Cancer
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: California Cancer Registry
state: California
city: Denver
country: United States
facility: Colorado Cancer Registry
state: Colorado
city: Hartford
country: United States
facility: Connecticut Cancer Registry
state: Connecticut
city: Atlanta
country: United States
facility: Georgia Cancer Registry
state: Georgia
city: Iowa City
country: United States
facility: Iowa Cancer Registry
state: Iowa
city: Bethesda
country: United States
facility: National Cancer Institute (NCI), 9000 Rockville Pike
state: Maryland
city: New Brunswick
country: United States
facility: New Jersey Cancer Registry
state: New Jersey
city: Albany
country: United States
facility: New York Cancer Registry
state: New York
city: Seattle
country: United States
facility: Seattle Cancer Registry
state: Washington
Study officials:
affiliation: National Cancer Institute (NCI)
name: Eric A Engels, M.D.
role: PRINCIPAL_INVESTIGATOR
References: