Specimen Collection for Validation of a New urine-based bladder cancer test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational study will gather urine samples at baseline and follow participants for up to five years, collecting urine, tissue (when available), and clinical data from routine care visits. Urine will be collected using Convergent Genomics’ urine collection system. Participants include adults with bladder cancer, upper tract urothelial carcinoma, or those with hematuria under evaluation, including patients scheduled for TURBT, biopsy, NAC, radical cystectomy, or ongoing surveillance. The study aims to correlate biospecimens with clinical outcomes to validate the UroAmp sequencing platform for detection and surveillance of urothelial carcinoma.

Why it matters

Who can join: the full rules

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

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Urology San Diego
  Oceanside, California, United States Active not recruiting
• Genesis Research, LLC
  San Diego, California, United States Active not recruiting
• Urology Associates of Silicon Valley
  San Jose, California, United States Active not recruiting
• UroPartners, LLC
  Chicago, Illinois, United States Active not recruiting
• UroPartners, LLC
  Grayslake, Illinois, United States Active not recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.