Bladder CancerINSITENCT07673016
Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
An observational study of Bladder Cancer and Urothelial Carcinoma (UC), run by Convergent Genomics, Inc. at 23 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma (UC), Hematuria
- How many people
- 2,500 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 15 Oct 2019to Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 2 countries
United States21 sites, 1 recruiting
- Active, not recruiting
Urology Austin - Round Rock
Austin, Texas, 78681
- Active, not recruiting
Midtown Urology Associates
Austin, Texas, 78705
- Active, not recruiting
Urology Austin - Medical Park Tower
Austin, Texas, 78759
- Active, not recruiting
UroPartners, LLC
Chicago, Illinois, 60657
- Active, not recruiting
The Urology Group
Cincinnati, Ohio, 45212
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Perla Lopez, 214-645-8787, Perla.Lopez@utsouthwestern.edu
- Active, not recruiting
UroPartners, LLC
Grayslake, Illinois, 60030
- Active, not recruiting
Chesapeake Urology Research Associates
Hanover, Maryland, 21076
- Active, not recruiting
Sheldon J. Freedman MD LTD
Las Vegas, Nevada, 89144
- Active, not recruiting
UroPartners, LLC
Mount Prospect, Illinois, 60056
- Active, not recruiting
Urology Associates, P.C.
Nashville, Tennessee, 37209
- Active, not recruiting
Manhattan Medical Research Practice
New York, New York, 10016
- Active, not recruiting
UroPartners, LLC
Niles, Illinois, 60068
- Active, not recruiting
Urology San Diego
Oceanside, California, 92056
- Active, not recruiting
Comprehensive Urology
Royal Oak, Michigan, 48073
- Active, not recruiting
Urology San Antonio
San Antonio, Texas, 78229
- Active, not recruiting
UT Health San Antonio
San Antonio, Texas, 78229
- Active, not recruiting
Genesis Research, LLC
San Diego, California, 92123
- Active, not recruiting
Urology Associates of Silicon Valley
San Jose, California, 95124
- Active, not recruiting
Urology of Virginia
Virginia Beach, Virginia, 23462
- Active, not recruiting
UroPartners, LLC
Wheaton, Illinois, 60187
Puerto Rico2 sites
- Active, not recruiting
Ashford Med Center
San Juan, 00907
- Active, not recruiting
PanOncology
San Juan, 00935
About this study
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.
Read the 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.
- Keywords
- Non-muscle invasive bladder cancer, Muscle invasive bladder cancer, Upper tract urothelial carcinoma, Urine tumor DNA
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Hematuria, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC) | Not described | |
| Hematuria Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival (RFS)
RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma
Measured: 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.
Measured: From enrollment through completion of diagnostic evaluation, up to 5 years.
Secondary outcomes (2)
Comparison to Alternative Urine Biomarkers
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.
Measured: From enrollment up to 5 years.
Lead Time for Detection of Cancer Recurrence
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.
Measured: From enrollment up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start15 Oct 2019
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Convergent Genomics, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673016
- Sponsor's protocol ID
- CG-001
- Acronym
- INSITE
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified patient data, inclusive of clinical risk factors, tumor staging and recurrence outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
- ClinicalTrials.gov ID
- NCT07673016
- Acronym / sponsor ID
- INSITE / CG-001
- Keywords
- Non-muscle invasive bladder cancer, Muscle invasive bladder cancer, Upper tract urothelial carcinoma, Urine tumor DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Convergent Genomics, Inc.Research network
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC) | – | – |
| Hematuria Controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
2 secondary outcomes
Comparison to Alternative Urine Biomarkers
Time frame: From enrollment up to 5 years.
Lead Time for Detection of Cancer Recurrence
Time frame: From enrollment up to 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified patient data, inclusive of clinical risk factors, tumor staging and recurrence outcomes.
Related trials for Bladder Cancer
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Urothelial Carcinoma (UC), run by Convergent Genomics, Inc. at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival (RFS) (time frame: From enrollment through completion of available clinical follow-up, up to 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.