The Pre-treatment Detection of Circulating, Functional, Prostate Cells Among Adenocarcinoma Patients: an Evaluation of the EPISPOT Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 361
- 试验地点
- 10
- 主要终点
- The difference between AUCs for the EPISPOT and Cellsearch Techniques
研究概览
简要总结
The primary objective of this study is to evaluate the predictive value (in terms of remission) of a new technique for detecting circulating, functional, prostate cells among patients with localized adenocarcinoma of the prostate, and prior to any treatment.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Histologically proven presence of prostate adenocarcinoma
- •Localized disease on digital rectal examination
- •Cancer without extensions
- •Acceptance of a curative treatment by the patient
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is taking a hormone-modifying treatment
- •Patient taking adrogenic supplements
研究组 & 干预措施
All study patients
All patients included according to stated inclusion and exclusion criteria.
干预措施: EPISPOT detection of the number of circulating cells (Biological)
All study patients
All patients included according to stated inclusion and exclusion criteria.
干预措施: CellSearch detection of the number of circulating, functional, prostate cells (Biological)
结局指标
主要结局
The difference between AUCs for the EPISPOT and Cellsearch Techniques
时间窗: 1 day
The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells
次要结局
未报告次要终点