NCT00966095Unknown不适用
A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy
Source MDx17 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2009年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 17
- 主要终点
- ability of whole blood gene expression to predict biopsy outcome
研究概览
简要总结
The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male over the age of
- •Patient is scheduled for prostate biopsy for one or more of the following reasons:
- •PSA > 2.5 ng/ml
- •Rising PSA (>0.5 ng/ml/yr)
- •Lower PSA value with other risk factors for prostate cancer (e.g.; family history)
- •Abnormal DRE
- •Percent free PSA <15%
- •No prior history of prostate cancer or prostate biopsy.
排除标准
- •Unable or unwilling to provide informed consent
结局指标
主要结局
ability of whole blood gene expression to predict biopsy outcome
时间窗: pre-biopsy
次要结局
- Prediction of tumor aggressiveness using whole blood gene expression(post-biopsy)
研究者
研究点 (17)
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