Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria

What this Trial Is About

Researchers are studying the use of Bladder EpiCheck, a urine test, to detect urothelial carcinoma in adults aged 45 years or older who have experienced blood in their urine (haematuria). This observational study aims to confirm how accurately the Bladder EpiCheck test identifies urothelial carcinoma compared to standard methods like cystoscopy and pathology when performed. The study focuses on participants undergoing evaluation for haematuria to improve detection methods for bladder-related cancers. Participants will provide a urine sample that will be tested using Bladder EpiCheck. The results of this test will not be shared with the clinical care team or the participant, and their usual medical care will continue unchanged. The study collects data from the standard diagnostic work-up for haematuria, including cystoscopy scheduled within 60 days after enrollment. During the study, participants will provide at least 10 ml of voided urine and undergo standard cystoscopy as part of their routine evaluation. Researchers will assess the sensitivity and specificity of the Bladder EpiCheck test to detect urothelial carcinoma within six months following enrollment. The study includes monitoring for high-grade urothelial carcinoma and compares Bladder EpiCheck's performance to urine cytology. Participation requires adherence to study procedures and will continue through the diagnostic process without altering treatment plans.

Bladder EpiCheck European Haematuria Study