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

This study is currently recruiting participants.
Verified August 18, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904579
First Posted: May 19, 2009
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  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
Immunocompromised Host Organ Transplantation Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cancer Risk in Solid Organ Transplant Recipients and End-Stage Renal Disease: The Transplant Cancer Match Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cancer

Estimated Enrollment: 1929901
Study Start Date: July 1, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904579


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

Locations
United States, California
California Cancer Registry Recruiting
Sacramento, California, United States, 95811
United States, Colorado
Colorado Cancer Registry Recruiting
Denver, Colorado, United States, 12206
United States, Connecticut
Connecticut Cancer Registry Recruiting
Hartford, Connecticut, United States, 06134
United States, Georgia
Georgia Cancer Registry Recruiting
Atlanta, Georgia, United States, 30303
United States, Iowa
Iowa Cancer Registry Recruiting
Iowa City, Iowa, United States, 52242
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   
United States, New Jersey
New Jersey Cancer Registry Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
New York Cancer Registry Recruiting
Albany, New York, United States, 12206
United States, Washington
Seattle Cancer Registry Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Eric A Engels, M.D. National Cancer Institute (NCI)
  More Information

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00904579     History of Changes
Obsolete Identifiers: NCT01445574
Other Study ID Numbers: 999906194
06-C-N194
First Submitted: May 16, 2009
First Posted: May 19, 2009
Last Update Posted: October 19, 2017
Last Verified: August 18, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Organ Transplants
Immunosuppression
Cancer
End Stage Renal Disease
ESRD
Cancer Risk

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