NCT07673016Recruiting
Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2500 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 15 Oct 2019
- Primary completion date
- Dec 2034
- Lead sponsor
- Convergent Genomics, Inc.
- Diseases
- Bladder cancer
- NCT number
- NCT07673016
What you commit to
- Study type: Observational
- Planned participants: 2500
- From 15 Oct 2019 to the primary completion date, Dec 2034
- 23 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ashford Med Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Active, not recruiting |
| PanOncology Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Active, not recruiting |
| Urology Austin - Medical Park Tower Coordinator of this site? Confirm its status | Austin | United States | Active, not recruiting |
| Midtown Urology Associates Coordinator of this site? Confirm its status | Austin | United States | Active, not recruiting |
| Urology Austin - Round Rock Coordinator of this site? Confirm its status | Austin | United States | Active, not recruiting |
| UroPartners,LLC Coordinator of this site? Confirm its status | Chicago | United States | Active, not recruiting |
| The Urology Group Coordinator of this site? Confirm its status | Cincinnati | United States | Active, not recruiting |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| UroPartners, LLC Coordinator of this site? Confirm its status | Grayslake | United States | Active, not recruiting |
| Chesapeake Urology Research Associates Coordinator of this site? Confirm its status | Hanover | United States | Active, not recruiting |
| Sheldon J. Freedman MD LTD Coordinator of this site? Confirm its status | Las Vegas | United States | Active, not recruiting |
| UroPartners, LLC Coordinator of this site? Confirm its status | Mount Prospect | United States | Active, not recruiting |
| Urology Associates, P.C. Coordinator of this site? Confirm its status | Nashville | United States | Active, not recruiting |
| Manhattan Medical Research Practice Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| UroPartners, LLC Coordinator of this site? Confirm its status | Niles | United States | Active, not recruiting |
| Urology San Diego Coordinator of this site? Confirm its status | Oceanside | United States | Active, not recruiting |
| Comprehensive Urology Coordinator of this site? Confirm its status | Royal Oak | United States | Active, not recruiting |
| UT Health San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Active, not recruiting |
| Urology San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Active, not recruiting |
| Genesis Research, LLC Coordinator of this site? Confirm its status | San Diego | United States | Active, not recruiting |
| Urology Associates of Silicon Valley Coordinator of this site? Confirm its status | San Jose | United States | Active, not recruiting |
| Urology of Virginia Coordinator of this site? Confirm its status | Virginia Beach | United States | Active, not recruiting |
| UroPartners, LLC Coordinator of this site? Confirm its status | Wheaton | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.