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

NCT07673016 | Recruiting

• 1 other identifier: CG-001
• Study Type: observational
• Target: 2,500
• Locations: 2 countries
• Sites: 23

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Recurrence Free Survival (RFS)

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

  From enrollment through completion of available clinical follow-up, up to 5 years.

• Diagnostic Detection Performance in Hematuria Triage

  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.

  From enrollment through completion of diagnostic evaluation, up to 5 years.

Secondary Outcomes (2)

• Comparison to Alternative Urine Biomarkers

  From enrollment up to 5 years.

• Lead Time for Detection of Cancer Recurrence

  From enrollment up to 5 years.

Study Arms (2)

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

Hematuria Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Convergent Genomics, Inc.: lead

Study Sites (23)

Urology San Diego

Oceanside, California, 92056, United States

ACTIVE NOT RECRUITING

Genesis Research, LLC

San Diego, California, 92123, United States

ACTIVE NOT RECRUITING

Urology Associates of Silicon Valley

San Jose, California, 95124, United States

ACTIVE NOT RECRUITING

UroPartners, LLC

Chicago, Illinois, 60657, United States

ACTIVE NOT RECRUITING

UroPartners, LLC

Grayslake, Illinois, 60030, United States

ACTIVE NOT RECRUITING

UroPartners, LLC

Mount Prospect, Illinois, 60056, United States

ACTIVE NOT RECRUITING

UroPartners, LLC

Niles, Illinois, 60068, United States

ACTIVE NOT RECRUITING

UroPartners, LLC

Wheaton, Illinois, 60187, United States

ACTIVE NOT RECRUITING

Chesapeake Urology Research Associates

Hanover, Maryland, 21076, United States

ACTIVE NOT RECRUITING

Comprehensive Urology

Royal Oak, Michigan, 48073, United States

ACTIVE NOT RECRUITING

Sheldon J. Freedman MD LTD

Las Vegas, Nevada, 89144, United States

ACTIVE NOT RECRUITING

Manhattan Medical Research Practice

New York, New York, 10016, United States

ACTIVE NOT RECRUITING

The Urology Group

Cincinnati, Ohio, 45212, United States

ACTIVE NOT RECRUITING

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

ACTIVE NOT RECRUITING

Urology Austin - Round Rock

Austin, Texas, 78681, United States

ACTIVE NOT RECRUITING

Midtown Urology Associates

Austin, Texas, 78705, United States

ACTIVE NOT RECRUITING

Urology Austin - Medical Park Tower

Austin, Texas, 78759, United States

ACTIVE NOT RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Urology San Antonio

San Antonio, Texas, 78229, United States

ACTIVE NOT RECRUITING

UT Health San Antonio

San Antonio, Texas, 78229, United States

ACTIVE NOT RECRUITING

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

ACTIVE NOT RECRUITING

Ashford Med Center

San Juan, 00907, Puerto Rico

ACTIVE NOT RECRUITING

PanOncology

San Juan, 00935, Puerto Rico

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Hematuria; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urination Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 29, 2026
• Study Start: October 15, 2019
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

PR (2); US (21)