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

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

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 Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Diagnostic test: Urine collection (150ml); Other: Blood sample (20 ml)

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancerologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Collaborators: Vitadx
• Investigators: Principal Investigator: Eschwège Pascal, MD, PhD, Institut de Cancerologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Diagnosis; Bladder Tumor; FGFR3; VisioCyt; FGFR3 Mutation; Cytoloogy
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2021-A01054-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No