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