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.
Study Type
OBSERVATIONAL
Enrollment
800
The 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.
NHS Fife
Dunfermline, Fife, United Kingdom
RECRUITINGAddenbrooke's Hospital
Cambridge, United Kingdom
RECRUITINGNHS Lothian
Edinburgh, United Kingdom
RECRUITINGGuy's and St Thomas
London, United Kingdom
RECRUITINGFrimley
Surrey Quays, United Kingdom
RECRUITINGThe 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).
Time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Non-inferiority of Bladder EpiCheck overall sensitivity vs. cytology in detection of primary urothelial carcinoma
Time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
Non-inferiority of Bladder EpiCheck specificity vs. cytology in detection of primary urothelial carcinoma
Time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
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.
Time frame: urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
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