Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nucleix Ltd.
- 入组人数
- 1,050
- 试验地点
- 6
- 主要终点
- Specificity (the proportion of negatives that are correctly identified as such by the gold standard)
研究概览
简要总结
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.
详细描述
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 22 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
- •Has all urothelial cell carcinoma tumor resected within the past 12 months
- •Has a plan for cystoscopic surveillance
排除标准
- •Planning to undergo radical cystectomy or chemotherapy-radiation for UCC
结局指标
主要结局
Specificity (the proportion of negatives that are correctly identified as such by the gold standard)
时间窗: Day 1
the proportion of negatives that are correctly identified as such by the gold standard
Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)
时间窗: Day 1
the proportion of positives that are correctly identified as such by the gold standard
次要结局
未报告次要终点