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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorConvergent Genomics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Clinical, symptomatic urinary tract infection at time of initial urine collection

Unable to provide adequate urine sample

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,500 Participants
are grouped into 2 trial groups

Sponsors and collaborators