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临床试验/NCT01221168
NCT01221168招募中不适用

ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial

Centre de Recherche sur les Pathologies Prostatiques5 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 1996年10月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
5
主要终点
Performance of genetic and molecular factors in predicting the risk of prostate cancer

研究概览

简要总结

The aims of the study are:

  • to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment,
  • to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.

详细描述

The impact of genetic factors on the natural history of prostate cancer (PC) is shown schematically at two levels:

  1. first, at the constitutional level with germline alterations. Family history is found in 20% of PC patients. Different clinical entities associated with different modes of inheritance, susceptibility mutations or polymorphisms, define different evolutionary patterns. Also, studies suggested that some genetic polymorphisms alter the response to some treatments (such as recurrence after prostatectomy or radiotherapy) or adverse effects of those above (such as toxicity of radiation therapy).
  2. secondly, PC is characterized by the accumulation of genetic alterations (somatic alterations or acquired mutations). These changes contribute in varying degrees to the aggressiveness of the disease (such as early metastatic potential) and treatment failure (such as resistance to radiation or hormone resistance).

The purpose of this study is to establish a register, with a follow up of cohort type and a collection of biological samples:

  • For men with known prostate cancer.
  • For men with no prostate cancer after a screening procedure for this disease, so that their biological samples can be compared to those of men with prostate cancer.

The registry data and collected biological samples are used to identify genetic and molecular factors involved in susceptibility, genesis and evolution of prostate cancers.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • patient with a histological confirmed prostate cancer
  • member of a hereditary prostate cancer family
  • healthy control men without prostate cancer

排除标准

  • Absence of signed informed consent
  • refusal to participate in the study

结局指标

主要结局

Performance of genetic and molecular factors in predicting the risk of prostate cancer

时间窗: 20 years

Logistic regression and artificial neural networks will be used

次要结局

未报告次要终点

研究者

发起方
Centre de Recherche sur les Pathologies Prostatiques
申办方类型
Other
责任方
Sponsor

研究点 (5)

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