Study of Cancers After Solid Organs Transplants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants

Conditions
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Cancer, Organ Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cancer as transplant indication ( except liver ) HIV positive

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient-Case<br>Transplanted patient with cancer | |
| Patient-Control<br>Transplanted patient without cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cancer among transplanted patients. |  | At the day of blood collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of the tumors. |  | At the day of blood collection | 
| Risk factors of the tumors. |  | At the day of blood collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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organ transplant, cancer, biobank, immunosuppressive drugs, lymphoma