Bladder EpiCheck European Haematuria Study
Recruiting
Observational Study
Hematuria
Cystoscopy
Urothelial Carcinoma Bladder
Urothelial Carcinoma of the Renal Pelvis and Ureter
Urothelial Carcinoma of the Urinary Bladder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 45 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 800 (estimated)
- Sponsor
- Nucleix Ltd. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Participants aged 45 years or older
2. Participants who are willing and able to provide written informed consent and adhere to study procedures
3. Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
4. Participants sche…