View Clinical Trial (Medical Research Study)
Cancer Risk in Solid Organ Transplant Recipients and End-Stage Renal Disease: The Transplant Cancer Match Study
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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End-Stage Renal Disease |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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- 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.
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| NCT ID: |
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NCT01445574 |
| Primary Contact: |
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Eric A. Engels, M.D.
Phone: (301) 435-4722
Email: engelse@exchange.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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