跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
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:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
已完成
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

申办方类型
Industry
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验

终止
不适用
ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy SettingProstate Cancer
NCT04357717Exosome Diagnostics, Inc.150
已完成
不适用
Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)Cancer of Prostate
NCT03031418Exosome Diagnostics, Inc.532
招募中
不适用
ExoDx Prostate Evaluation in Active Surveillance Patient PopulationProstate Cancer
NCT05572099Exosome Diagnostics, Inc.750
招募中
3 期
Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled TrialHepatocellular Carcinoma Resectable
NCT05766605Zhujiang Hospital90
终止
不适用
PASCUAL (Prostate Assay Specific Clinical Utility at Launch) StudyProstate Cancer
NCT02250313MDx Health600
Clinical Evaluation of ExoDx Prostate(IntelliScore)... | 临床试验