Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
Recruiting
Observational Study
Bladder CancerUrothelial Carcinoma (UC)HematuriaUpper Tract Urothelial Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
2,500 (estimated)
Sponsor
Convergent Genomics, Inc. · Research network
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 en…
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
Contacts
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