Collecting urine and tumor samples to test a genetic test for bladder cancer
Gathers urine and tumor samples from adults being checked or treated for urothelial cancer.
Plain-language title generated from the registry record
Registry title: Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
Key facts
- Where
- San Juan, Puerto RicoSee the 2 sites
Where in Puerto Rico
- Ashford Med CenterSan Juan, Puerto RicoNo longer taking part
- PanOncologySan Juan, Puerto RicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Convergent Genomics, Inc.
- Trial code
- NCT07673016
- Record updated
- 29 June 2026
- Original description
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.Read full original descriptionShow less
Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
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.
Inclusion: 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.
Exclusion: GROUP 1: Bladder Cancer and/or Upper Tract UCC; Clinical, symptomatic urinary tract infection at time of initial urine collection; Evidence and/or History of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection; Unable to provide adequate urine sample; GROUP 2: Hematuria Controls.