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.
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 with history of urothelial cancer in the bladder and/or upper urinary tract
Participants who had prior cystoscopy for haematuria within the past 2 years
Participants previously enrolled in this study
Participants treated for prostate cancer within the last 12 months
aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma
Cohort
Prospective
Bladder EpiCheck
Diagnostic testThe participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test. The clinical care team and the participant will not be informed of the result, and the standard of care will not change.
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma
The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma, calculated versus the Reference Standard defined by cystoscopy, imaging, and, if indicated, pathological confirmation) in participants presenting with haematuria (visible and/or non-visible).
Non-inferiority of Bladder EpiCheck overall sensitivity vs. cytology in detection of primary urothelial carcinoma
Non-inferiority of Bladder EpiCheck specificity vs. cytology in detection of primary urothelial carcinoma
Further validate the sensitivity of the Bladder EpiCheck test to detect pathologically confirmed high-grade urothelial carcinoma, including HG non-muscle invasive and muscle invasive disease.
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