Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection… (NCT07673016) | Clinical Trial Compass
RecruitingNot Applicable
Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
United States, Puerto Rico2,500 participantsStarted 2019-10-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Cli…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence Free Survival (RFS)
Timeframe: From enrollment through completion of available clinical follow-up, up to 5 years.
2
Diagnostic Detection Performance in Hematuria Triage
Timeframe: From enrollment through completion of diagnostic evaluation, up to 5 years.