Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: Urine collection (150ml)
* Other: Blood sample (20 ml)


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA BOTH GROUPS M/F Patient agrees to follow study protocol and is able to follow study procedures Patient signed, dated and understood consent form Patient has a social security scheme CASE GROUP Patient is 18 or older Patient for whom a bladder cancer recently diagnosed, or backsliding/progression is heavily suspected after the initial fibroscopy Patient who hasn't started systemic/oral/radiotheurapeutic pelvic treatment for his/her tumor CONTROL GROUP Patient between 18 and 45 y/o Patient not suspected of having any bladder cancer Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology Patient who hasn't been exposed to bladder carcinogens (tobacco, industrial carcinogen (ex: coal tar, tar/coal oils, coal pitch and burning coal soot), urinary bilharzia, chemotherapy exposition (cyclophosphamid) Patient that had a negative cytopathological exploration of the excretory urinary route OR/AND iconography (pelvic echography, pelvic scanner) OR/AND endoscopy with prior urinary sample Patient unscathed of any cancer that might interact with bladder cancer : uterine cancer, prostate cancer, rectal cancer, and metastasis from other cancer or non-urologic tumor invading the bladder EXCLUSION CRITERIA BOTH GROUPS Non-treated current urinary infection Patient with another pelvic cancer Bladder cancer outside of urothelial carcinoma Associated carcinoma of the high urinary apparatus Patient that received renal transplantation (BK virus) Patient that received pelvis radiotherapy (related to prostatic cancer, gynecologic cancer or pelvic digestive cancer) Patient having a JJ catheter Refused to signed consent Pregnant, susceptible to be, or breast-feeding women Person Under guardianship Impossibility to submit to medical monitoring because of geographic, social, or mental issues CASE GROUP • Under 18y/o CONTROL GROUP • Under 18y/o or above 45 y/o

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case<br>Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy | Diagnostic Test: Urine collection (150ml)<br>* 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)<br>Other: Blood sample (20 ml)<br>* 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.<br>|
| Experimental: Control<br>Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology | Diagnostic Test: Urine collection (150ml)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the 4 different tests | Sensibility Comparaison between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology | at inclusion | 
| Specificity of the 4 different tests | Specificity Comparaison between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology | at inclusion | 
| Positive predictive value of the 4 different tests | Positive predictive value between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology | at inclusion | 
| Negative predictive value of the 4 different tests | Negative predictive value between : Visiocyt test + FGFR3 analysis FGFR3 analysis on its own Visiocyt test on its own Standard cytology | at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis, FGFR3, VisioCyt, Bladder Tumor, Cancer, FGFR3 Mutation, Cytoloogy