Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 23
- 主要终点
- Recurrence Free Survival (RFS)
研究概览
简要总结
This is a prospective, multicenter observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.
详细描述
All study participants will provide a urine sample at baseline, study enrollment. Each participant will then be followed longitudinally for up to 5 years during which urine, tissue (if applicable), and clinical data will be collected from the standard of care clinical visits. Urine samples will be collected in Convergent Genomics' proprietary urine collection system.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GROUP 1: Bladder Cancer and/or Upper Tract UCC
- •Male or female ≥ 18 years of age who are scheduled for transurethral resection of bladder tumor (TURBT) and/or biopsy of urinary tract or
- •Patients on surveillance who are negative for recurrence or tumor at the time of study enrollment but have had previous urothelial cell carcinoma (UCC) or
- •Patients with muscle invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC) scheduled for NAC and/or subsequent radical cystectomy (RC)
- •Able to provide consent prior to diagnostic TURBT, nephroureterectomy, or administration of NAC and/or RC
- •Able to provide at least 20cc urine. If patient cannot void sufficient volume of urine, urologist can pull urine from the bladder via catheter or cystoscope. Urine should not be collected immediately after resection
- •Participation in other bladder cancer studies is allowed. Experimental therapy must be documented in the case report forms
- •GROUP 2: Hematuria Controls
- •Male or female ≥ 18 years of age presenting with gross or microscopic hematuria as defined by standard of care
- •No evidence of and/or history of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection
- •Able to provide consent
- •Able to provide at least 20cc urine
- •Participation in other studies is allowed. Experimental therapy must be documented in the case report forms
排除标准
- •GROUP 1: Bladder Cancer and/or Upper Tract UCC
- •Clinical, symptomatic urinary tract infection at time of initial urine collection
- •Unable to provide adequate urine sample
- •GROUP 2: Hematuria Controls
- •- Evidence and/or History of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection
研究组 & 干预措施
Hematuria Controls
Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC)
结局指标
主要结局
Recurrence Free Survival (RFS)
时间窗: From enrollment through completion of available clinical follow-up, up to 5 years.
RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma
Diagnostic Detection Performance in Hematuria Triage
时间窗: From enrollment through completion of diagnostic evaluation, up to 5 years.
Sensitivity, specificity, positive predictive value and negative predictive value of the investigational urine assay for the detection of urothelial cancer among subjects undergoing evaluation for hematuria, comparing subjects with histopathologically confirmed cancer to subjects without evidence of cancer at the time of diagnostic workup.
次要结局
- Comparison to Alternative Urine Biomarkers(From enrollment up to 5 years.)
- Lead Time for Detection of Cancer Recurrence(From enrollment up to 5 years.)