Clinical trial · Interventional
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
NCT02700464CI-TRIAL-00051599completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bladder EpiCheck Urine Test | Device | — | UNRESOLVED |
| Cystoscopy and pathology | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bladder EpiCheck Urine Test
- description
- Bladder EpiCheck Urine Test
- interventionNames
- Device: Bladder EpiCheck Urine Test
- type
- ACTIVE_COMPARATOR
- label
- Gold Standard
- description
- Cystoscopy and pathology
- interventionNames
- Procedure: Cystoscopy and pathology
Primary outcomes (2)
- measure
- Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals. * Has had all urothelial cell carcinoma tumor resected within the past 12 months * Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed) * Able to provide legally effective informed consent * Able to produce 45mL of urine Exclusion Criteria: * Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma
References
Publications (0)
Data not yet available
No reference posted for this study.