Bladder EpiCheck European Haematuria Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Bladder EpiCheck: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma — urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
  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).

Trial sites (5)