Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

Overview

It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.

This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in urine) from US sites. This study will be conducted with subjects with a previous history of microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma. The study will aim to recruit an equal number of microscopic and gross hematuria patients, controlling the proportion of gross hematuria subjects recruited by targeting an approximate 1:1 ratio of microscopic to gross hematuria patients. Consented, eligible subjects will undergo all standard of care tests as clinically indicated. In addition, one additional urine sample, using remote (at-home) or at-clinic sampling, will be collected to validate the performance characteristics for the Cxbladder Triage-Plus test. The urine sample collected from each subject will be a voided urine sample within 90 days prior to the scheduled cystoscopy or within 10 weeks post-cystoscopy. The primary aim of this study is to validate the use of Cxbladder Triage-Plus as an effective diagnostic tool to: 1. Enable patients with microscopic hematuria who have a low probability of having disease (urothelial carcinoma) to be ruled out from further investigation. This could avoid expensive, invasive work-up, without compromising detection of disease. 2. Allow physicians to identify subjects at higher risk of disease (urothelial carcinoma) 3. Replace less sensitive urine-based tests (such as urine cytology or other urine genomic tests currently available) Cxbladder results will not be reported to the subjects or the physicians. Each subject will be required to fill in the date of sample collection in the test-request form and Cxbladder tubes. The site will fill in case-report forms in a professional manner in accordance with good clinical practice (GCP).