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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Organ Transplantation; Immunocompromised Host

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.

• Study Type: Observational
• Enrollment (Anticipated): 19929901

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95811
      • California Cancer Registry
  • Colorado
    • Denver, Colorado, United States, 12206
      • Colorado Cancer Registry
  • Connecticut
    • Hartford, Connecticut, United States, 06134
      • Connecticut Cancer Registry
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Georgia Cancer Registry
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Iowa Cancer Registry
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Cancer Institute (NCI), 9000 Rockville Pike
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • New Jersey Cancer Registry
  • New York
    • Albany, New York, United States, 12206
      • New York Cancer Registry
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Registry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Cancer patients who have had organ transplants identified through the transplant and cancer registries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer	Cancer patients who have had organ transplants identified through the transplant and cancer registries.	End of study

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eric A Engels, M.D., National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2006
• Primary Completion (Actual): April 22, 2020
• Study Completion (Actual): April 22, 2020

Study Registration Dates

• First Submitted: May 16, 2009
• First Submitted That Met QC Criteria: May 16, 2009
• First Posted (Estimate): May 19, 2009

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Immunosuppression; Cancer; End Stage Renal Disease; ESRD; Organ Transplants; Cancer Risk
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 999906194; 06-C-N194

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No