Immunocompromised HostNCT00904579
Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease
An observational study of Immunocompromised Host and Organ Transplantation, run by National Cancer Institute (NCI) at 9 sites in United States.
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… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Immunocompromised Host, Organ Transplantation, Cancer
- How many people
- 19,929,901 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jul 2006to 22 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cancer patients who have had organ transplants identified through the transplant and cancer registries.@@@
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New York Cancer Registry
Albany, New York, 12206
Georgia Cancer Registry
Atlanta, Georgia, 30303
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
Colorado Cancer Registry
Denver, Colorado, 12206
Connecticut Cancer Registry
Hartford, Connecticut, 06134
Iowa Cancer Registry
Iowa City, Iowa, 52242
New Jersey Cancer Registry
New Brunswick, New Jersey, 08901
California Cancer Registry
Sacramento, California, 95811
Seattle Cancer Registry
Seattle, Washington, 98109
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Immunocompromised Host, Organ Transplantation, Cancer
- Keywords
- Organ Transplants, Immunosuppression, Cancer, End Stage Renal Disease, ESRD, Cancer Risk
- Medical subject headings
- Neoplasms, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cancer patients who have had organ transplants identified through the transplant and cancer registries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer
Cancer patients who have had organ transplants identified through the transplant and cancer registries.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study start1 Jul 2006
- Primary completion22 Apr 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunocompromised HostStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19,929,901 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric A Engels, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904579
- Sponsor's protocol ID
- 999906194
- Other IDs
- 06-C-N194
- Status last verified
- Apr 2020
- First submitted
- 16 May 2009
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Risk in Solid Organ Transplant Recipients and End-Stage Renal Disease: The Transplant Cancer Match Study
- ClinicalTrials.gov ID
- NCT00904579
- Acronym / sponsor ID
- 999906194
- Conditions
- Immunocompromised Host, Organ Transplantation, Cancer
- Keywords
- Organ Transplants, Immunosuppression, Cancer, End Stage Renal Disease, ESRD, Cancer Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,929,901 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Jul 2006 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Cancer patients who have had organ transplants identified through the transplant and cancer registries. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients who have had organ transplants identified through the transplant and cancer registries.@@@
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer
Time frame: End of study
Cancer patients who have had organ transplants identified through the transplant and cancer registries.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A Engels, M.D. principal investigator
National Cancer Institute (NCI)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunocompromised Host and Organ Transplantation, run by National Cancer Institute (NCI) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.