Study of Cancers After Solid Organs Transplants

Completed

• Conditions: Cancer; Organ Transplantation

• Registration Number: NCT00948883
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

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Exclusion Criteria

• Cancer as transplant indication ( except liver )
• HIV positive

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cancer among transplanted patients.	At the day of blood collection

Secondary Outcome Measures

Name	Time	Method
Characteristics of the tumors.	At the day of blood collection
Risk factors of the tumors.	At the day of blood collection

Trial Locations

Locations (1)

Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris; 🇫🇷 Le Kremlin Bicetre Cedex, France