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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00904579
First received: May 16, 2009
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

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.

Condition
End-Stage Renal Disease

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1929901
Study Start Date: June 2006
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. The investigators propose linking a database of U.S. transplant recipients (458,834 transplants, 1987-June 2010), donors, and wait list candidates, and to multiple U.S. cancer registries. This linkage will allow identification of incident cancers in transplant recipients. Using these data, investigators will conduct a detailed evaluation of the spectrum of cancer risk in transplant recipients. Additionally, the investigators will examine cancer risk in transplant recipients in relation to whether donors themselves had cancer, to study possible donor-to-recipient transmission of cancer. The investigators will also study whether proposed cancer risk factors (e.g., underlying medical condition, infection with oncogenic viruses, immunosuppressive medications), documented in transplant files, are associated with increased risk of particular types of cancer.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904579

Contacts
Contact: Eric A Engels, M.D. (301) 435-4722 engelse@exchange.nih.gov

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Eric Engels, M.D.    301-435-4722    engelse@exchange.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Eric A Engels, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00904579     History of Changes
Obsolete Identifiers: NCT01445574
Other Study ID Numbers: 999906194, 06-C-N194
Study First Received: May 16, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunosuppression
Lymphoma
Kaposi Sarcoma
Infection
Dialysis
End Stage Renal Disease
ESRD
Cancer Risk

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on July 20, 2014