跳至主要内容
临床试验/NCT05572099
NCT05572099招募中不适用

ExoDx Prostate Evaluation in Active Surveillance Patient Population

Exosome Diagnostics, Inc.1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
750
试验地点
1
主要终点
Develop and evaluate risk-based scoring using the ExoDx Prostate test.

研究概览

简要总结

The goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.

详细描述

The current trial seeks to evaluate the role of the ExoDx Prostate test in men with low and favorable intermediate prostate cancer undergoing an active surveillance regimen.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

排除标准

  • Clinical symptoms of urinary tract infection at time of enrollment.
  • History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment.
  • Known hepatitis or HIV
  • History of concurrent renal/bladder tumors

结局指标

主要结局

Develop and evaluate risk-based scoring using the ExoDx Prostate test.

时间窗: 1yr after last enrolled patient

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 (1)

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