Actively Recruiting
Bladder EpiCheck European Haematuria Study
Led by Nucleix Ltd. · Updated on 2026-01-22
800
Participants Needed
5
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Bladder EpiCheck European Haematuria Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 45 years or older
- Willing and able to provide written informed consent and follow study procedures
- Presenting with visible or non-visible haematuria within 6 months before enrollment
- Scheduled for standard cystoscopy within 60 days after enrollment
- Able to provide at least 10 ml of voided urine
You will not qualify if you...
- History of urothelial cancer in bladder or upper urinary tract
- Cystoscopy for haematuria within the past 2 years
- Previously enrolled in this study
- Treated for prostate cancer within the last 12 months
- Treated for kidney cancer within the last 12 months
- Untreated urinary tract infection
- Symptomatic urinary tract stones (e.g., flank pain)
- On dialysis for end stage renal failure
- Has a long term urinary catheter
- Pregnancy (self-reported)
- Medical status or frailty prevents completion of the diagnostic pathway
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
NHS Fife
Dunfermline, Fife, United Kingdom, KY12 OSU
Actively Recruiting
2
Addenbrooke's Hospital
Cambridge, United Kingdom
Actively Recruiting
3
NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
4
Guy's and St Thomas
London, United Kingdom
Actively Recruiting
5
Frimley
Surrey Quays, United Kingdom
Actively Recruiting
Research Team
V
Vered Yayon
CONTACT
A
Admin.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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