C67
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Initial TURBT for non–muscle-invasive urothelial carcinoma of the urinary bladder (NMIBC) Minimum age of 18 years Informed consent
Exclusion criteria
Exclusion criteria: Macroscopically incomplete initial TURBT (according to the surgeon’s assessment) Concomitant carcinoma in situ / urothelial carcinoma of the upper urinary tract Muscle-invasive urothelial carcinoma of the urinary bladder (MIBC) Recurrent urothelial carcinoma of the urinary bladde
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: sensitivity, specificity, PPV, NPV, and AUC of a biomarker panel for the detection of residual tumor at re-TURBT. For this purpose, the developed urinary biomarker panel (proteomic analysis) will be compared with the histopathological report of the re-TURBT. Urine will be collected at the time of re-TURBT and subjected to further proteomic analysis. Measurement time point: day of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| see primary endpoints, sex-specific analyses | — |
Countries
Germany
Contacts
Klinik für Urologie des UKSH Campus Lübeck