Bladder EpiCheck European Haematuria Study (NCT06818136) | Clinical Trial Compass
RecruitingNot Applicable
Bladder EpiCheck European Haematuria Study
United Kingdom800 participantsStarted 2025-06-20
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma
Timeframe: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up