Cystoscopy, Hematuria, Urothelial Carcinoma Bladder, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma of the Urinary Bladder
Conditions
Keywords
urine test, methylation, primary detection
Brief 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.
Interventions
DIAGNOSTIC_TESTBladder 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.
Sponsors
Nucleix Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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 scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment 5. Participants who are able to produce at least 10 ml of voided urine
Exclusion criteria
1. Participants with history of urothelial cancer in the bladder and/or upper urinary tract 2. Participants who had prior cystoscopy for haematuria within the past 2 years 3. Participants previously enrolled in this study 4. Participants treated for prostate cancer within the last 12 months 5. Participants treated for kidney cancer within the last 12 months 6. Participants with untreated urinary tract infection 7. Participants with symptomatic urinary tract stones (e.g. flank pain) 8. Participants on dialysis for end stage renal failure 9. Participants with a long term urinary catheter 10. Pregnancy (self-reported) 11. Participants 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 | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame |
|---|---|
| Non-inferiority of Bladder EpiCheck overall sensitivity vs. cytology in detection of primary urothelial carcinoma | 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 | 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. | urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up |
Countries
United Kingdom
Contacts
CONTACTVered Yayon
CONTACTAdmin.
PRINCIPAL_INVESTIGATORParamananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS
Western General Hospital, Edinburgh
Outcome results
None listed