NCT01499381已完成不适用
Evaluation of a Novel Circulating Microvesicle-Based Multi-analyte Assay for the Detection of Prostate Cancer in Men With Elevated Risk for Prostate Cancer; the EMBRACE1 Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,290
- 试验地点
- 1
- 主要终点
- Carisome Prostate Assay with prostate biopsy outcome
研究概览
简要总结
The objective of this multi-center prospective observational clinical study is to evaluate the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of the Carisome Prostate assay will be compared with pathology results of prostate biopsy procedures. Secondarily, the performance of the Carisome Prostate test will be compared to the current standard of care for the detection of prostate cancer.
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
- •Men scheduled for a routine prostate biopsy expected to produce a pathology evaluation and report
- •Blood draw within 7 days prior to scheduled prostate biopsy procedure
- •Blood draw on the day of but prior to biopsy
排除标准
- •Any previous diagnosis of cancer with the exception of non-melanoma skin cancer
- •Any prior or ongoing treatment for prostate cancer including prostatectomy or hormone therapy
- •Prostate biopsy within one month of blood draw
- •Previous enrollment in the Caris Life Sciences Biorepository
结局指标
主要结局
Carisome Prostate Assay with prostate biopsy outcome
时间窗: up to 6 months
Association of Carisome Prostate Assay result with prostate biopsy outcome
次要结局
未报告次要终点
研究者
研究点 (1)
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