NCT07673016 · Convergent Genomics, Inc.
Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
(INSITE)
What this study is about
This is a forward-looking, conducted at multiple hospitals observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Oceanside, California
- San Diego, California
- San Jose, California
- Chicago, Illinois
- Grayslake, Illinois
- Mount Prospect, Illinois
- Niles, Illinois
- Wheaton, Illinois
- Hanover, Maryland
- Royal Oak, Michigan
- Las Vegas, Nevada
- New York, New York
And 6 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations