Bladder Cancer
Conditions
Keywords
Bladder cancer, Urine, Methylation
Brief summary
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.
Detailed description
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.
Interventions
OTHERBladder EpiCheck
Urine test for the monitoring of bladder cancer recurrence
Sponsors
Nucleix Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma * Has all urothelial cell carcinoma tumor resected within the past 12 months * Has a plan for cystoscopic surveillance
Exclusion criteria
* Planning to undergo radical cystectomy or chemotherapy-radiation for UCC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity (the proportion of positives that are correctly identified as such by the gold standard) | Day 1 | the proportion of positives that are correctly identified as such by the gold standard |
| Specificity (the proportion of negatives that are correctly identified as such by the gold standard) | Day 1 | the proportion of negatives that are correctly identified as such by the gold standard |
Countries
Germany, Israel, Netherlands, Spain
Outcome results
None listed