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

June 24, 2026 updated by: Convergent Genomics, Inc.

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - San Juan, Puerto Rico, 00907
    - Active, not recruiting
    - Ashford Med Center
  - San Juan, Puerto Rico, 00935
    - Active, not recruiting
    - PanOncology
United States
- California
  - Oceanside, California, United States, 92056
    - Active, not recruiting
    - Urology San Diego
  - San Diego, California, United States, 92123
    - Active, not recruiting
    - Genesis Research, LLC
  - San Jose, California, United States, 95124
    - Active, not recruiting
    - Urology Associates of Silicon Valley
- Illinois
  - Chicago, Illinois, United States, 60657
    - Active, not recruiting
    - UroPartners, LLC
  - Grayslake, Illinois, United States, 60030
    - Active, not recruiting
    - UroPartners, LLC
  - Mount Prospect, Illinois, United States, 60056
    - Active, not recruiting
    - UroPartners, LLC
  - Niles, Illinois, United States, 60068
    - Active, not recruiting
    - UroPartners, LLC
  - Wheaton, Illinois, United States, 60187
    - Active, not recruiting
    - UroPartners, LLC
- Maryland
  - Hanover, Maryland, United States, 21076
    - Active, not recruiting
    - Chesapeake Urology Research Associates
- Michigan
  - Royal Oak, Michigan, United States, 48073
    - Active, not recruiting
    - Comprehensive Urology
- Nevada
  - Las Vegas, Nevada, United States, 89144
    - Active, not recruiting
    - Sheldon J. Freedman MD LTD
- New York
  - New York, New York, United States, 10016
    - Active, not recruiting
    - Manhattan Medical Research Practice
- Ohio
  - Cincinnati, Ohio, United States, 45212
    - Active, not recruiting
    - The Urology Group
- Tennessee
  - Nashville, Tennessee, United States, 37209
    - Active, not recruiting
    - Urology Associates, P.C.
- Texas
  - Austin, Texas, United States, 78681
    - Active, not recruiting
    - Urology Austin - Round Rock
  - Austin, Texas, United States, 78705
    - Active, not recruiting
    - Midtown Urology Associates
  - Austin, Texas, United States, 78759
    - Active, not recruiting
    - Urology Austin - Medical Park Tower
  - Dallas, Texas, United States, 75390
    - Recruiting
    - UT Southwestern Medical Center
    - Contact:
      
      Perla Lopez
      
      Phone Number: 214-645-8787
      
      Email: Perla.Lopez@utsouthwestern.edu
  - San Antonio, Texas, United States, 78229
    - Active, not recruiting
    - Urology San Antonio
  - San Antonio, Texas, United States, 78229
    - Active, not recruiting
    - UT Health San Antonio
- Virginia
  - Virginia Beach, Virginia, United States, 23462
    - Active, not recruiting
    - Urology of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC)
Hematuria Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Free Survival (RFS) Time Frame: 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	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison to Alternative Urine Biomarkers Time Frame: From enrollment up to 5 years.	Comparison of the investigational urine biomarker to alternative urine biomarker assays, including cytology and UroVysion FISH, for the detection of urothelial cancer recurrence. Comparison will include lead time, sensitivity, specificity, negative predictive value, and positive predictive value.	From enrollment up to 5 years.
Lead Time for Detection of Cancer Recurrence Time Frame: From enrollment up to 5 years.	A subject with diagnostic lead time will be defined as a subject with a negative cystoscopy and concurrent positive investigational urine biomarker with confirmed urothelial cancer recurrence on study. Lead time will be calculated as the time from the positive urine biomarker result to the date of histopathologic confirmation.	From enrollment up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Convergent Genomics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2034

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)