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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
190
Urine collection will be tacken at inclusion. The sample will be thereafter separate into three to realise different analyzes (standard cytology, Visiocyt test, FGFR3 analysis)
Blood sample will be tacken at inclusion, ONLY for "case" patients that agreed upon this. This sample will be addition to the collection for further research.
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Specificity
Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own
Time frame: at inclusion
Sensitivity of the 4 different tests
Sensibility Comparaison between : 1. Visiocyt test + FGFR3 analysis 2. FGFR3 analysis on its own 3. Visiocyt test on its own 4. Standard cytology
Time frame: at inclusion
Specificity of the 4 different tests
Specificity Comparaison between : 1. Visiocyt test + FGFR3 analysis 2. FGFR3 analysis on its own 3. Visiocyt test on its own 4. Standard cytology
Time frame: at inclusion
Positive predictive value of the 4 different tests
Positive predictive value between : 1. Visiocyt test + FGFR3 analysis 2. FGFR3 analysis on its own 3. Visiocyt test on its own 4. Standard cytology
Time frame: at inclusion
Negative predictive value of the 4 different tests
Negative predictive value between : 1. Visiocyt test + FGFR3 analysis 2. FGFR3 analysis on its own 3. Visiocyt test on its own 4. Standard cytology
Time frame: at inclusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.