NCT06020807已完成不适用
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nucleix Ltd.
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Specificity
研究概览
简要总结
This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder 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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 22 or older
- •Able to sign the informed consent form
- •Normal, healthy subjects or subjects with one of the following conditions:
- •Benign non-genitourinary disease (e.g. heart disease)
- •Non-genitourinary cancers (e.g. lung, CRC, breast)
- •Genitourinary disease other than bladder cancer including:
- •Benign prostatic hyperplasia (BPH)
- •Microhematuria proven negative for bladder cancer through prior UCC evaluation
- •Inflammation/infection
- •Symptomatic sexually transmitted disease (STD)
- •Urinary tract stones
- •Genitourinary trauma
- •Subjects with native bladder
排除标准
- •Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive)
- •Currently in work-up due to suspicion of cancer of any kind
结局指标
主要结局
Specificity
时间窗: Day 1
The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.
次要结局
未报告次要终点
研究者
研究点 (1)
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