Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Recurrence Free Survival (RFS) [Срок оценки: From enrollment through completion of available clinical follow-up, up to 5 years.]
• Diagnostic Detection Performance in Hematuria Triage [Срок оценки: From enrollment through completion of diagnostic evaluation, up to 5 years.]

Вторичные конечные точки (2)

• Comparison to Alternative Urine Biomarkers [Срок оценки: From enrollment up to 5 years.]
• Lead Time for Detection of Cancer Recurrence [Срок оценки: From enrollment up to 5 years.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 21 центр

• Urology San Diego — Oceanside
• Genesis Research, LLC — San Diego
• Urology Associates of Silicon Valley — San Jose
• UroPartners, LLC — Chicago
• UroPartners, LLC — Grayslake
• UroPartners, LLC — Mount Prospect
• UroPartners, LLC — Niles
• UroPartners, LLC — Wheaton
• … и ещё 13 центров

Пуэрто-Рико · 2 центра

• Ashford Med Center — San Juan
• PanOncology — San Juan

Идентификаторы

NCT: NCT07673016 · CG-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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