Clinical Trial

Bladder EpiCheck European Haematuria Study

Recruiting
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Summary
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed. Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-04; most recent amendment 2026-01-21.
Status change: Not Yet Recruiting → Recruiting 2025-12-21
Trial Details
NCT Number NCT06818136
Lead Sponsor Nucleix Ltd.
Conditions Hematuria, Cystoscopy, Urothelial Carcinoma Bladder, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma of the Urinary Bladder
Enrollment 800 participants
Start Date 2025-06-20
Primary Completion 2026-08 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-22