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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904579
• Other study ID #: 999906194
• Secondary ID: 06-C-N194
• Status: Completed
• Start date: July 1, 2006
• Est. completion date: April 22, 2020

Study information

• Verified date: April 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01445574

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19929901
• Est. completion date: April 22, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Cancer
• Immunocompromised Host
• Kidney Diseases
• Kidney Failure, Chronic
• Organ Transplantation

Locations

Country	Name	City	State
United States	New York Cancer Registry	Albany	New York
United States	Georgia Cancer Registry	Atlanta	Georgia
United States	National Cancer Institute (NCI), 9000 Rockville Pike	Bethesda	Maryland
United States	Colorado Cancer Registry	Denver	Colorado
United States	Connecticut Cancer Registry	Hartford	Connecticut
United States	Iowa Cancer Registry	Iowa City	Iowa
United States	New Jersey Cancer Registry	New Brunswick	New Jersey
United States	California Cancer Registry	Sacramento	California
United States	Seattle Cancer Registry	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer	Cancer patients who have had organ transplants identified through the transplant and cancer registries.	End of study