NCT06818136Recruiting
Bladder EpiCheck European Haematuria Study
Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- Jun 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- Nucleix Ltd.
- Diseases
- Bladder cancer
- NCT number
- NCT06818136
What you commit to
- Study type: Observational
- Planned participants: 800
- From Jun 2025 to the primary completion date, Aug 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who had prior cystoscopy for haematuria within the past 2 years
- Participants previously enrolled in this study
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| NHS Fife Coordinator of this site? Confirm its status | Dunfermline | United Kingdom | Recruiting |
| NHS Lothian Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| Guy's and St Thomas Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Frimley Coordinator of this site? Confirm its status | Surrey Quays | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.