Status:
RECRUITING
Bladder EpiCheck European Haematuria Study
Lead Sponsor:
Nucleix Ltd.
Conditions:
Hematuria
Cystoscopy
Eligibility:
All Genders
45+ years
Brief 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 pres...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Key Trial Info
Start Date :
June 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06818136
Start Date
June 20 2025
End Date
December 1 2026
Last Update
January 22 2026
Active Locations (5)
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1
NHS Fife
Dunfermline, Fife, United Kingdom, KY12 OSU
2
Addenbrooke's Hospital
Cambridge, United Kingdom
3
NHS Lothian
Edinburgh, United Kingdom
4
Guy's and St Thomas
London, United Kingdom