Urothelial carcinoma Cancer
Conditions
Interventions
Participants will be asked to attend their routine hospital appointment, and at this appointment provide a urine sample. There will be no additional hospital visits required for this research. This ur
Sponsors
Nucleix (Israel)
Eligibility
Sex/Gender
All
Age
45 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 45 years or older 2. Subjects who are willing and able to provide written informed consent and adhere to study procedures 3. Subjects presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment 4. Subjects scheduled to undergo standard-of-care cystoscopy for urinary bladder examination within 60 days after study enrollment 5. Subjects who are able to produce at least 10 ml of voided urine
Exclusion criteria
Exclusion criteria: 1. Subjects with history of urothelial cancer in the bladder and/or upper urinary tract 2. Subjects who had prior cystoscopy for haematuria within the past 2 years 3. Subjects previously enrolled in this study 4. Subjects treated for prostate cancer within the last 12 months 5. Subjects treated for kidney cancer within the last 12 months 6. Subjects with untreated urinary tract infection 7. Subjects with symptomatic urinary tract stones (e.g. flank pain) 8. Subjects on dialysis for end-stage renal failure 9. Subjects with a long-term urinary catheter 10. Pregnancy (self-reported) 11. Subjects who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 subjects presenting with haematuria (visible and/or non-visible). Measured at a single timepoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at a single timepoint: 1. Non-inferiority of Bladder EpiCheck overall sensitivity vs cytology in the detection of primary urothelial carcinoma 2. Non-inferiority of Bladder EpiCheck specificity vs cytology in the detection of primary urothelial carcinoma 3. The sensitivity of the Bladder EpiCheck test to detect pathologically confirmed high-grade urothelial carcinoma, including HG non-muscle invasive and muscle-invasive disease | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactJack Kerrigan
Outcome results
None listed