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UroAmp Validation for Bladder Cancer Detection

This study is collecting urine and tumor samples, along with health information, from people with bladder cancer or those being checked for it. The goal is to help validate UroAmp, a new technology that uses next-generation sequencing to find and monitor bladder cancer. We want to see how well UroAmp can detect cancer recurrence (when cancer comes back) and help doctors decide the best steps for people with blood in their urine (hematuria). You can join if you are 18 or older and have bladder cancer, upper tract urothelial carcinoma (a type of cancer in the urinary tract), or blood in your urine. The study is currently collecting samples and information.

Study design
This is an observational study planning to enroll 2500 participants. It is not specified if there are different treatment groups.
What's involved
You will provide a urine sample at the start of the study. You will then be followed for up to 5 years, during which more urine, tissue (if needed), and health information will be collected during your regular doctor visits.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 5 years to track cancer recurrence and diagnostic outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07673016

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

Recruiting
Not specifiedAges 18+Observational
Convergent Genomics, Inc.
~2,500 participants
Updated 2026-06-29 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence Free Survival (RFS)
Measured over From enrollment through completion of available clinical follow-up, up to 5 years.
+1 more outcome measured

Conditions

Bladder Cancer
Urothelial Carcinoma (UC)
Hematuria
Upper Tract Urothelial Cancer

Explore related trials

Bladder CarcinomaHematuriaRenal Pelvis and Ureter Urothelial CarcinomaUrothelial CarcinomaUrine tumor DNA

Where it's being run

23 sites across 11 states
Texas6
Illinois5
California3
Puerto Rico2
Maryland1
Michigan1
Nevada1
New York1

Who to contact

Perla Lopez
[email protected]
214-645-8787
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Clinical, symptomatic urinary tract infection at time of initial urine collection
Unable to provide adequate urine sample

What this trial measures

  • Recurrence Free Survival (RFS)From enrollment through completion of available clinical follow-up, up to 5 years.

    RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma

  • Diagnostic Detection Performance in Hematuria TriageFrom enrollment through completion of diagnostic evaluation, up to 5 years.

    Sensitivity, specificity, positive predictive value and negative predictive value of the investigational urine assay for the detection of urothelial cancer among subjects undergoing evaluation for hematuria, comparing subjects with histopathologically confirmed cancer to subjects without evidence of cancer at the time of diagnostic workup.