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:
- 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).
- 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
- 是
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
研究点 (5)
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