NCT07187063招募中不适用
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Lahey Clinic
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Number of cystoscopies
研究概览
简要总结
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AUA high-risk bladder cancer1
- •Received induction BCG or gemcitabine/docetaxel
- •Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)
排除标准
- •High-risk NMIBC within 3 years
- •Prior induction intravesical therapy
- •Variant histology
- •Concurrent upper tract disease
结局指标
主要结局
Number of cystoscopies
时间窗: From enrollment to 24 months
The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure.
次要结局
- Event-free survival(From enrollment to 24 months)
- Recurrence-free survival(From enrollment to 24 months)
- Patient-reported outcomes(From enrollment to 24 months)
研究者
研究点 (2)
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