Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Nucleix Ltd.
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma
研究概览
简要总结
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed.
Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 45 years or older
- •Participants who are willing and able to provide written informed consent and adhere to study procedures
- •Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
- •Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
- •Participants who are able to produce at least 10 ml of voided urine
排除标准
- •Participants with history of urothelial cancer in the bladder and/or upper urinary tract
- •Participants who had prior cystoscopy for haematuria within the past 2 years
- •Participants previously enrolled in this study
- •Participants treated for prostate cancer within the last 12 months
- •Participants treated for kidney cancer within the last 12 months
- •Participants with untreated urinary tract infection
- •Participants with symptomatic urinary tract stones (e.g. flank pain)
- •Participants on dialysis for end stage renal failure
- •Participants with a long term urinary catheter
- •Pregnancy (self-reported)
- •Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway
结局指标
主要结局
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma
时间窗: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma, calculated versus the Reference Standard defined by cystoscopy, imaging, and, if indicated, pathological confirmation) in participants presenting with haematuria (visible and/or non-visible).
次要结局
- Non-inferiority of Bladder EpiCheck overall sensitivity vs. cytology in detection of primary urothelial carcinoma(urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up)
- Further validate the sensitivity of the Bladder EpiCheck test to detect pathologically confirmed high-grade urothelial carcinoma, including HG non-muscle invasive and muscle invasive disease.(urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up)
- Non-inferiority of Bladder EpiCheck specificity vs. cytology in detection of primary urothelial carcinoma(urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up)