RecruitingNCT06818136

Bladder EpiCheck European Haematuria Study

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

Sponsor

Nucleix Ltd.

Enrollment

800 participants

Start Date

Jun 20, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a urine test called Bladder EpiCheck to see how well it can detect bladder cancer in people who have blood in their urine. It is being conducted across Europe. **You may be eligible if...** - You are 45 years old or older - You have had visible or non-visible blood in your urine within the last 6 months - You are already scheduled to have a bladder camera exam (cystoscopy) - You can provide a urine sample of at least 10 ml **You may NOT be eligible if...** - You have a history of bladder, ureter, or kidney cancer - You had a bladder camera exam for blood in the urine within the past 2 years - You were previously enrolled in this study - You were treated for prostate or kidney cancer in the last 12 months - You have an active urinary tract infection or painful kidney stones - You are on dialysis or have a long-term urinary catheter - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBladder 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.