Study to Validate Cxbladder Urine Test for Detecting Urothelial Carcinoma in Adults with Microscopic or Gross Hematuria Scheduled for Cystoscopy

What this Trial Is About

Researchers are evaluating the use of Cxbladder, a non-invasive urine-based test, for detecting urothelial carcinoma bladder cancer in patients with microscopic hematuria, which means blood in the urine not visible to the naked eye. The study addresses concerns about the current invasive standard procedure, cystoscopy, which can cause discomfort and anxiety, especially since the risk of bladder cancer in this group is relatively low. This observational study aims to determine if Cxbladder can help identify patients who need further investigation and reduce unnecessary invasive procedures. This multicenter study will enroll up to 1000 subjects with either microscopic or gross hematuria from US sites. Participants are patients referred to urology and scheduled for cystoscopy. During the study, participants will provide an additional urine sample either at home or in the clinic, collected within 90 days before or up to 10 weeks after cystoscopy. The study will compare Cxbladder test results with standard diagnostic procedures to validate its performance in detecting urothelial carcinoma and stratifying risk. Participants will undergo standard care tests and cystoscopy as scheduled. They will complete forms about urine sample collection dates. Researchers will collect data professionally according to clinical standards. The main outcome is to validate Cxbladders accuracy in identifying patients at low risk who might avoid invasive testing and those at higher risk needing further care. The study does not share Cxbladder results with patients or doctors. Participation involves urine sample collection and data recording, with the study lasting through the scheduled cystoscopy and sample evaluations.

Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria