Tests a urine test for bladder cancer in adults with blood in urine
Studies a urine test, Bladder EpiCheck, to detect bladder cancer in people 45 or older.
Plain-language title generated from the registry record
Registry title: Bladder EpiCheck European Haematuria Study
Key facts
- Where
- Cambridge, Dunfermline, Edinburgh, London, and Surrey Quays, United KingdomSee the 5 sites
Where in United Kingdom
- Addenbrooke's HospitalCambridge, United KingdomTaking people
- NHS FifeDunfermline, United KingdomTaking people
- NHS LothianEdinburgh, United KingdomTaking people
- Guy's and St ThomasLondon, United KingdomTaking people
- FrimleySurrey Quays, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nucleix Ltd.
- Trial code
- NCT06818136
- Record updated
- 22 January 2026
- Original description
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.Read full original descriptionShow less
Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
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.
Inclusion: 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: Participants who had prior cystoscopy for haematuria within the past 2 years; Participants previously enrolled in this study; Participants with history of urothelial cancer in the bladder and/or upper urinary tract; 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 on dialysis for end stage renal failure; Participants with symptomatic urinary tract stones (e.g. flank pain); 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.