临床试验/NCT04720599

NCT04720599已完成不适用

Clinical Evaluation of ExoDx™ Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

Exosome Diagnostics, Inc.3 个研究点分布在 2 个国家目标入组 120 人开始时间: 2020年6月1日最近更新: 2021年9月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Exosome Diagnostics, Inc.
入组人数: 120
试验地点: 3
主要终点: Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.

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: 50 Years 至 —（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Clinical suspicion for prostate cancer
•Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
•Scheduled for a initial prostate biopsy

排除标准

•Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
•History of prostate cancer.
•History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
•Known hepatitis status (all types) and/or HIV documented in patient's medical record.
•Patients with history of concurrent renal/bladder tumors.
•Prior MRI used in the decision to biopsy

结局指标

主要结局

Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方

Exosome Diagnostics, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (3)

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