Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors
- Conditions
- Bladder Cancer
- Interventions
- Diagnostic Test: Urine collection (150ml)Other: Blood sample (20 ml)
- Registration Number
- NCT05151341
- Lead Sponsor
- Institut de Cancérologie de Lorraine
- Brief Summary
This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer.
The case are patient in whom newly diagnosed, or recurring /progressing bladder cancer is strongly suspected after initial fibroscopy.
The control are patient attending or hospitalized for urolithiasis, urinary infections, urinary superior excretory stones or with non suspect urinary symptomatology.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Urine collection (150ml) Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology Case Urine collection (150ml) Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy Case Blood sample (20 ml) Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy
- Primary Outcome Measures
Name Time Method Specificity at inclusion Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own
- Secondary Outcome Measures
Name Time Method Specificity of the 4 different tests at inclusion Specificity Comparaison between :
1. Visiocyt test + FGFR3 analysis
2. FGFR3 analysis on its own
3. Visiocyt test on its own
4. Standard cytologyPositive predictive value of the 4 different tests at inclusion Positive predictive value between :
1. Visiocyt test + FGFR3 analysis
2. FGFR3 analysis on its own
3. Visiocyt test on its own
4. Standard cytologySensitivity of the 4 different tests at inclusion Sensibility Comparaison between :
1. Visiocyt test + FGFR3 analysis
2. FGFR3 analysis on its own
3. Visiocyt test on its own
4. Standard cytologyNegative predictive value of the 4 different tests at inclusion Negative predictive value between :
1. Visiocyt test + FGFR3 analysis
2. FGFR3 analysis on its own
3. Visiocyt test on its own
4. Standard cytology
Trial Locations
- Locations (1)
Institut de Cancérologie de Lorraine
🇫🇷Vandœuvre-lès-Nancy, France