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临床试验/NCT00948883
NCT00948883已完成不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
330
试验地点
1
主要终点
Incidence of cancer among transplanted patients.

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Incidence of cancer among transplanted patients.

时间窗: At the day of blood collection

次要结局

  • Characteristics of the tumors.(At the day of blood collection)
  • Risk factors of the tumors.(At the day of blood collection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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