Study of Cancers After Solid Organs Transplants (K-GREF)
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|ClinicalTrials.gov Identifier: NCT00948883|
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : April 4, 2013
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).
|Condition or disease|
|Cancer Organ Transplantation|
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 Type :||Observational|
|Actual Enrollment :||330 participants|
|Observational Model:||Case Control|
|Official Title:||Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Transplanted patient with cancer
Transplanted patient without cancer
- Incidence of cancer among transplanted patients. [ Time Frame: At the day of blood collection ]
- 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 ]
Biospecimen Retention: Samples With DNA
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): NCT00948883
|Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris|
|Le Kremlin Bicetre Cedex, France, 94275|
|Principal Investigator:||Michel MARTY, MD||Assistance Publique - Hôpitaux de Paris|