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NCT07673016Recruiting

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

Convergent Genomics, Inc.

Start Date

10/15/2019

Completion Date

12/1/2034

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.

Detailed Description

All study participants will provide a urine sample at baseline, study enrollment. Each participant will then be followed longitudinally for up to 5 years during which urine, tissue (if applicable), and clinical data will be collected from the standard of care clinical visits. Urine samples will be collected in Convergent Genomics' proprietary urine collection system.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Bladder CancerUrothelial Carcinoma (UC)HematuriaUpper Tract Urothelial Cancer

Locations

Urology San Diego

Oceanside, California 92056

United States

Genesis Research, LLC

San Diego, California 92123

United States

Urology Associates of Silicon Valley

San Jose, California 95124

United States

UroPartners, LLC

Chicago, Illinois 60657

United States

UroPartners, LLC

Grayslake, Illinois 60030

United States

UroPartners, LLC

Mount Prospect, Illinois 60056

United States

UroPartners, LLC

Niles, Illinois 60068

United States

UroPartners, LLC

Wheaton, Illinois 60187

United States

Chesapeake Urology Research Associates

Hanover, Maryland 21076

United States

Comprehensive Urology

Royal Oak, Michigan 48073

United States

Sheldon J. Freedman MD LTD

Las Vegas, Nevada 89144

United States

Manhattan Medical Research Practice

New York, New York 10016

United States

The Urology Group

Cincinnati, Ohio 45212

United States

Urology Associates, P.C.

Nashville, Tennessee 37209

United States

Urology Austin - Round Rock

Austin, Texas 78681

United States

Midtown Urology Associates

Austin, Texas 78705

United States

Urology Austin - Medical Park Tower

Austin, Texas 78759

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Urology San Antonio

San Antonio, Texas 78229

United States

UT Health San Antonio

San Antonio, Texas 78229

United States

Urology of Virginia

Virginia Beach, Virginia 23462

United States

Ashford Med Center

San Juan, 00907

Puerto Rico

PanOncology

San Juan, 00935

Puerto Rico