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

Recruiting now

Conditions studied: Bladder Cancer, Urothelial Carcinoma (UC), Hematuria, Upper Tract Urothelial Cancer

In brief

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.

Key facts

Study ID

NCT07673016

Run by

Convergent Genomics, Inc.

People needed

2500

Starts

2019-10-15

Expected to finish

2034-12-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Genesis Research, LLC — San Diego, California, United States
• Urology Associates of Silicon Valley — San Jose, California, United States
• UroPartners, LLC — Chicago, Illinois, United States
• UroPartners, LLC — Grayslake, Illinois, United States
• UroPartners, LLC — Mount Prospect, Illinois, United States
• UroPartners, LLC — Niles, Illinois, United States
• UroPartners, LLC — Wheaton, Illinois, United States
• Chesapeake Urology Research Associates — Hanover, Maryland, United States
• Comprehensive Urology — Royal Oak, Michigan, United States
• Sheldon J. Freedman MD LTD — Las Vegas, Nevada, United States
• Manhattan Medical Research Practice — New York, New York, United States
• The Urology Group — Cincinnati, Ohio, United States
• Urology Associates, P.C. — Nashville, Tennessee, United States
• Urology Austin - Round Rock — Austin, Texas, United States
• Midtown Urology Associates — Austin, Texas, United States
• Urology Austin - Medical Park Tower — Austin, Texas, United States
• Urology San Antonio — San Antonio, Texas, United States
• UT Health San Antonio — San Antonio, Texas, United States
• Urology of Virginia — Virginia Beach, Virginia, United States
• Ashford Med Center — San Juan, Puerto Rico
• Urology San Diego — Oceanside, California, United States
• PanOncology — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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