Bladder EpiCheck European Haematuria Study
Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
Nucleix Ltd.
800 participants
Jun 20, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- Participants aged 45 years or older
- Participants who are willing and able to provide written informed consent and adhere to study procedures
- Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
- Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
- Participants who are able to produce at least 10 ml of voided urine
Exclusion Criteria11
- Participants with history of urothelial cancer in the bladder and/or upper urinary tract
- Participants who had prior cystoscopy for haematuria within the past 2 years
- Participants previously enrolled in this study
- Participants treated for prostate cancer within the last 12 months
- Participants treated for kidney cancer within the last 12 months
- Participants with untreated urinary tract infection
- Participants with symptomatic urinary tract stones (e.g. flank pain)
- Participants on dialysis for end stage renal failure
- Participants with a long term urinary catheter
- Pregnancy (self-reported)
- Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway
Interventions
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.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06818136