Validating a New Multiplex ELISA Urine Test for Detecting Bladder Cancer in Adults with Microscopic Hematuria

What this Trial Is About

Researchers are exploring a new multiplex ELISA assay to improve the non-invasive detection of bladder cancer BCa in patients who have microscopic hematuria, a common sign of BCa. This study aims to validate this diagnostic test, which targets a BCa-associated signature in urine samples, to overcome limitations of existing urine-based tests that miss many early or low-grade cancers. Detecting BCa early is crucial since current methods often require invasive bladder examinations. The study involves collecting voided urine samples from patients with microscopic hematuria and analyzing them using the multiplex ELISA assay. The performance of this assay will be compared to standard diagnostic procedures, including cystoscopy, which involves inserting a camera into the bladder, and other urine tests like VUC and NMP-22 BladderChek. This comparison will help confirm the sensitivity and specificity of the new assay within one year. Participants will provide urine samples and undergo cystoscopy and upper tract imaging as part of the hematuria evaluation. Researchers will measure how accurately the multiplex ELISA assay detects bladder cancer compared to current methods. The study includes monitoring for diagnostic performance over a year, with participants expected to complete the full hematuria evaluation during that time. The total duration of participation varies but centers on the one-year outcome assessment.

A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer