Study of Cancers After Solid Organs Transplants (K-GREF)
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).
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants|
- Incidence of cancer among transplanted patients. [ Time Frame: At the day of blood collection ] [ Designated as safety issue: Yes ]
- Characteristics of the tumors. [ Time Frame: At the day of blood collection ] [ Designated as safety issue: No ]
- Risk factors of the tumors. [ Time Frame: At the day of blood collection ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood, frozen tissue
|Study Start Date:||October 2008|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Transplanted patient with cancer
Transplanted patient without cancer
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948883
|Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris|
|Le Kremlin Bicetre Cedex, France, 94275|
|Principal Investigator:||Michel MARTY, MD||Assistance Publique - Hôpitaux de Paris|