Recruiting

Observational Study

Sponsor:

Convergent Genomics, Inc.

Code:

NCT07673016

Conditions

Bladder Cancer

Urothelial Carcinoma (UC)

Hematuria

Upper Tract Urothelial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Bladder Cancer

Urothelial Carcinoma (UC)

Hematuria

Upper Tract Urothelial Cancer

Study ID

NCT07673016

Start date

Oct 15, 2019

Status verified date

Jun, 2026

Completion date

Dec, 2034

Anticipated

Primary completion date

Dec, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC)

Hematuria Controls

Primary outcome measure

  • Recurrence Free Survival (RFS) [ Time Frame: From enrollment through completion of available clinical follow-up, up to 5 years. ]
  • Diagnostic Detection Performance in Hematuria Triage [ Time Frame: From enrollment through completion of diagnostic evaluation, up to 5 years. ]

Central Contacts and Locations

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Perla Lopez

214-645-8787Perla.Lopez@utsouthwestern.edu

More Information

Sponsor

Convergent Genomics, Inc.

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Non-muscle invasive bladder cancer
  • Muscle invasive bladder cancer
  • Upper tract urothelial carcinoma
  • Urine tumor DNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Convergent Genomics, Inc. on 2026-06-29.