Clinical trial · Interventional
Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors
NCT02966691CI-TRIAL-00055819VISIOCYT 1completedN/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)
This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VisioCyt® diagnostic test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Patients 'sick'
- description
- The patients of this arm have a clinical signs of bladder cancer with : * a positive result of bladder endoscopy * or an negative endoscopy and a positive result of the conventional cytology The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice .This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized
- interventionNames
- Other: VisioCyt® diagnostic test
- type
- ACTIVE_COMPARATOR
- label
- Patients 'healthy'
- description
- The patients of this arm have no suspicion of bladder cancer with negative results of their bladder endoscopy and conventional cytology. The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Patient affiliated to a social security system * Patient able to understand the protocol. * Signature of patient consent form before the start of the study * Negative urine culture * Patient for which is programmed a bladder Endoscopy for : * suspected bladder cancer (de novo, monitoring or relapse) * Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer Exclusion Criteria: * Age \<18 years * Ongoing Urinary tract infection untreated * Private person of liberty or under guardianship (including guardianship) * Bladder cancer excluding urothelial carcinoma * Carcinoma of high urinary tract, associated * Lithiasis pathology * Patient who underwent renal transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.