The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nucleix Ltd.
- 入组人数
- 680
- 试验地点
- 11
- 主要终点
- Specificity of Bladder EpiCheck Urine Test Kit (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 efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.
详细描述
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
- •Has had all urothelial cell carcinoma tumor resected within the past 12 months
- •Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
- •Able to provide legally effective informed consent
- •Able to produce 45mL of urine
排除标准
- •Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma
研究组 & 干预措施
Bladder EpiCheck Urine Test
Bladder EpiCheck Urine Test
干预措施: Bladder EpiCheck Urine Test (Device)
Gold Standard
Cystoscopy and pathology
干预措施: Cystoscopy and pathology (Procedure)
结局指标
主要结局
Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)
时间窗: Day 1
Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)
时间窗: Day 1
次要结局
未报告次要终点