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Study of Cancers After Solid Organs Transplants

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赞助商
Assistance Publique - Hôpitaux de Paris
合作者
CANCEROPOLE Ile-de-France

关键词

抽象

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).

描述

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.

日期

最后验证: 03/31/2013
首次提交: 07/27/2009
提交的预估入学人数: 07/27/2009
首次发布: 07/28/2009
上次提交的更新: 04/02/2013
最近更新发布: 04/03/2013
实际学习开始日期: 09/30/2008
预计主要完成日期: 06/30/2011
预计完成日期: 06/30/2011

状况或疾病

Cancer
Organ Transplantation

-

手臂组

干预/治疗
Patient-Case
Transplanted patient with cancer
Patient-Control
Transplanted patient without cancer

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
取样方式Non-Probability Sample
接受健康志愿者
标准

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

结果

主要结果指标

1. Incidence of cancer among transplanted patients. [At the day of blood collection]

次要成果指标

1. Characteristics of the tumors. [At the day of blood collection]

2. Risk factors of the tumors. [At the day of blood collection]

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