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A simple urine test could revolutionize bladder cancer detection

NCT ID NCT07673016

Diagnosis Sponsor: Convergent Genomics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study is testing a new urine test called UroAmp to see if it can accurately detect bladder cancer and monitor for its return. Researchers will collect urine and tumor samples from 2,500 people being evaluated or treated for bladder cancer or related conditions. The goal is to find a non-invasive way to diagnose and track the disease, potentially reducing the need for invasive procedures like cystoscopy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
UroAmp urine test
What this could lead to
If successful, this urine test could replace invasive cystoscopies for bladder cancer detection and surveillance, making diagnosis easier and faster.
What could go wrong
This is an observational study, not a treatment trial. The test may not be accurate enough to replace current methods, and results are still being validated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients undergoing evaluation, treatment, or surveillance for urologic tract cancers, including bladder cancer, upper tract urothelial cell carcinoma, or urethral urothelial cell carcinoma, as well as individuals undergoing evaluation for hematuria. Participants are identified and enrolled at participating clinical sites.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Criteria: 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

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Conditions

The condition(s) this trial relates to.

Hematuria Non-Muscle Invasive Bladder Neoplasms renal pelvis/ureter urothelial carcinoma transitional cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer Hematuria Upper tract urothelial cancer Urothelial carcinoma (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ashford Med Center

    ACTIVE_NOT_RECRUITING

    San Juan, 00907, Puerto Rico

  • Chesapeake Urology Research Associates

    ACTIVE_NOT_RECRUITING

    Hanover, Maryland, 21076, United States

  • Comprehensive Urology

    ACTIVE_NOT_RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Genesis Research, LLC

    ACTIVE_NOT_RECRUITING

    San Diego, California, 92123, United States

  • Manhattan Medical Research Practice

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • Midtown Urology Associates

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78705, United States

  • PanOncology

    ACTIVE_NOT_RECRUITING

    San Juan, 00935, Puerto Rico

  • Sheldon J. Freedman MD LTD

    ACTIVE_NOT_RECRUITING

    Las Vegas, Nevada, 89144, United States

  • The Urology Group

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45212, United States

  • UT Health San Antonio

    ACTIVE_NOT_RECRUITING

    San Antonio, Texas, 78229, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • UroPartners, LLC

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60657, United States

  • UroPartners, LLC

    ACTIVE_NOT_RECRUITING

    Grayslake, Illinois, 60030, United States

  • UroPartners, LLC

    ACTIVE_NOT_RECRUITING

    Mount Prospect, Illinois, 60056, United States

  • UroPartners, LLC

    ACTIVE_NOT_RECRUITING

    Niles, Illinois, 60068, United States

  • UroPartners, LLC

    ACTIVE_NOT_RECRUITING

    Wheaton, Illinois, 60187, United States

  • Urology Associates of Silicon Valley

    ACTIVE_NOT_RECRUITING

    San Jose, California, 95124, United States

  • Urology Associates, P.C.

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Austin - Medical Park Tower

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78759, United States

  • Urology Austin - Round Rock

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78681, United States

  • Urology San Antonio

    ACTIVE_NOT_RECRUITING

    San Antonio, Texas, 78229, United States

  • Urology San Diego

    ACTIVE_NOT_RECRUITING

    Oceanside, California, 92056, United States

  • Urology of Virginia

    ACTIVE_NOT_RECRUITING

    Virginia Beach, Virginia, 23462, United States

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Other studies related to the condition(s) this trial covers.