NCT06818136

Bladder EpiCheck European Haematuria Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Nucleix Ltd. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematuria
• Cystoscopy
• Urothelial Carcinoma Bladder
• Urothelial Carcinoma of the Renal Pelvis and Ureter
• Urothelial Carcinoma of the Urinary Bladder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bladder EpiCheck	The participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test. The clinical care team and the participant will not be informed of the result, and the standard of care will not change.

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-02-10
• Last updated: 2026-01-22

Locations

5 sites across 1 country: United Kingdom