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OpenTrials
Completed

NCT Number: NCT00904579

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

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.

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Key information

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

California Cancer Registry, Sacramento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. Cancer

    Time frame: End of study

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

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2020
Study completion
2020
First posted
May 19, 2009
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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