CancerK-GREFNCT00948883
Study of Cancers After Solid Organs Transplants
An observational study of Cancer and Organ Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
About 1500 solid organs transplants are performed each year in the Paris agglomeration. Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Organ Transplantation
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Jul 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solid organ transplant who have developed a cancer. Patients with solid organ transplant who have not developed a cancer.
Who may be able to join
- Man or woman after 18 years old
- Transplanted with a solid organ (heart, kidney, lung,liver)
- Informed Consent Form signed
- For the patients-case: Patients who developed a post-transplant cancer
- For the patients-control: Patients who didn't develop a post-transplant cancer
Who cannot join
- Cancer as transplant indication ( except liver )
- HIV positive
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris
Le Kremlin-Bicêtre, 94275
About this study
Official title: Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants
About 1500 solid organs transplants are performed each year in the Paris agglomeration.
Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant.
Read more
These cancers can be related to many factors :
- Post-transplant cancers are due in part to the non specific immunosuppression, which leads to oncogenic viruses replication, and then produces virus inducted cancers (as lymphoma due to EBV virus).
- Post-transplant cancers can also be due to the carcinogenic factors of the immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear to have anti-cancer properties.
- Post-transplant cancers which are not virus-inducted can be relied to genetic factors of the transplanted patient and/or the transplant donor.
There are 4 axes in this study :
- Axis 1 : Epidemiological, clinical and biological study of the incident cancers in transplanted patients.
- Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the transplanted patient (determine their characteristics when a cancer appears).
- Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the cancer is caused by the donor or the recipient). Creation of a biobank.
- Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).
Read the detailed description
This is an observational and comparative study (2 control patients are recruited for each 1 case patient).
A case patient is a patient who has developed a cancer after his/her transplant.
A control patient is a patient who has not developed a cancer after his/her transplant.
These 2 groups will be matched according to specific inclusion criteria.
- Conditions
- Cancer, Organ Transplantation
- Keywords
- organ transplant, cancer, biobank, immunosuppressive drugs, lymphoma
- Medical subject headings
- Neoplasms, Lymphoma
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 |
|---|---|---|
| Patient-Case | Transplanted patient with cancer | |
| Patient-Control | Transplanted patient without cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cancer among transplanted patients.
Measured: At the day of blood collection
Secondary outcomes (2)
Characteristics of the tumors.
Measured: At the day of blood collection
Risk factors of the tumors.
Measured: At the day of blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Cancéropôle Ile De France
- Responsible party
- Sponsor
- Investigators
- Michel MARTY, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948883
- Sponsor's protocol ID
- DRCD CANC 0701
- Acronym
- K-GREF
- Status last verified
- Apr 2013
- First submitted
- 28 Jul 2009
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants
- ClinicalTrials.gov ID
- NCT00948883
- Acronym / sponsor ID
- K-GREF / DRCD CANC 0701
- Conditions
- Cancer, Organ Transplantation
- Keywords
- organ transplant, cancer, biobank, immunosuppressive drugs, lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Cancéropôle Ile De France
- Study start
- Oct 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Jul 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.
About 1500 solid organs transplants are performed each year in the Paris agglomeration.
Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant.
These cancers can be related to many factors :
- Post-transplant cancers are due in part to the non specific immunosuppression, which leads to oncogenic viruses replication, and then produces virus inducted cancers (as lymphoma due to EBV virus).
- Post-transplant cancers can also be due to the carcinogenic factors of the immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear to have anti-cancer properties.
- Post-transplant cancers which are not virus-inducted can be relied to genetic factors of the transplanted patient and/or the transplant donor.
There are 4 axes in this study :
- Axis 1 : Epidemiological, clinical and biological study of the incident cancers in transplanted patients.
- Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the transplanted patient (determine their characteristics when a cancer appears).
- Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the cancer is caused by the donor or the recipient). Creation of a biobank.
- Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).
Detailed description
This is an observational and comparative study (2 control patients are recruited for each 1 case patient).
A case patient is a patient who has developed a cancer after his/her transplant.
A control patient is a patient who has not developed a cancer after his/her transplant.
These 2 groups will be matched according to specific inclusion criteria.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Case | – | –Transplanted patient with cancer |
| Patient-Control | – | –Transplanted patient without cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid organ transplant who have developed a cancer. Patients with solid organ transplant who have not developed a cancer.
Key inclusion criteria (5 listed)
- Man or woman after 18 years old
- Transplanted with a solid organ (heart, kidney, lung,liver)
- Informed Consent Form signed
- For the patients-case: Patients who developed a post-transplant cancer
- For the patients-control: Patients who didn't develop a post-transplant cancer
Key exclusion criteria (2 listed)
- Cancer as transplant indication ( except liver )
- HIV positive
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
Incidence of cancer among transplanted patients.
Time frame: At the day of blood collection
2 secondary outcomes
Characteristics of the tumors.
Time frame: At the day of blood collection
Risk factors of the tumors.
Time frame: At the day of blood collection
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 4 Apr 2013.
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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.
Michel MARTY, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Organ Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Incidence of cancer among transplanted patients. (time frame: At the day of blood collection). 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 4 Apr 2013; AzTrials last refreshed its copy on 27 Oct 2026.