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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.
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

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ashford Med Center
Coordinator of this site? Confirm its status
San JuanPuerto RicoActive, not recruiting
PanOncology
Coordinator of this site? Confirm its status
San JuanPuerto RicoActive, not recruiting
Urology Austin - Medical Park Tower
Coordinator of this site? Confirm its status
AustinUnited StatesActive, not recruiting
Midtown Urology Associates
Coordinator of this site? Confirm its status
AustinUnited StatesActive, not recruiting
Urology Austin - Round Rock
Coordinator of this site? Confirm its status
AustinUnited StatesActive, not recruiting
UroPartners,LLC
Coordinator of this site? Confirm its status
ChicagoUnited StatesActive, not recruiting
The Urology Group
Coordinator of this site? Confirm its status
CincinnatiUnited StatesActive, not recruiting
UT Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
UroPartners, LLC
Coordinator of this site? Confirm its status
GrayslakeUnited StatesActive, not recruiting
Chesapeake Urology Research Associates
Coordinator of this site? Confirm its status
HanoverUnited StatesActive, not recruiting
Sheldon J. Freedman MD LTD
Coordinator of this site? Confirm its status
Las VegasUnited StatesActive, not recruiting
UroPartners, LLC
Coordinator of this site? Confirm its status
Mount ProspectUnited StatesActive, not recruiting
Urology Associates, P.C.
Coordinator of this site? Confirm its status
NashvilleUnited StatesActive, not recruiting
Manhattan Medical Research Practice
Coordinator of this site? Confirm its status
New YorkUnited StatesActive, not recruiting
UroPartners, LLC
Coordinator of this site? Confirm its status
NilesUnited StatesActive, not recruiting
Urology San Diego
Coordinator of this site? Confirm its status
OceansideUnited StatesActive, not recruiting
Comprehensive Urology
Coordinator of this site? Confirm its status
Royal OakUnited StatesActive, not recruiting
UT Health San Antonio
Coordinator of this site? Confirm its status
San AntonioUnited StatesActive, not recruiting
Urology San Antonio
Coordinator of this site? Confirm its status
San AntonioUnited StatesActive, not recruiting
Genesis Research, LLC
Coordinator of this site? Confirm its status
San DiegoUnited StatesActive, not recruiting
Urology Associates of Silicon Valley
Coordinator of this site? Confirm its status
San JoseUnited StatesActive, not recruiting
Urology of Virginia
Coordinator of this site? Confirm its status
Virginia BeachUnited StatesActive, not recruiting
UroPartners, LLC
Coordinator of this site? Confirm its status
WheatonUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.