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

NCT05151341 | Completed

• 1 other identifier: 2021-A01054-37
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

FGFR3; VisioCyt; Bladder Tumor; Cancer; FGFR3 Mutation; Diagnosis; Cytoloogy

Outcome Measures

Primary Outcomes (1)

• Specificity

  Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own

  at inclusion

Secondary Outcomes (4)

• Sensitivity of the 4 different tests

  at inclusion

• Specificity of the 4 different tests

  at inclusion

• Positive predictive value of the 4 different tests

  at inclusion

• Negative predictive value of the 4 different tests

  at inclusion

Study Arms (2)

Case

EXPERIMENTAL

Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy

Diagnostic Test: Urine collection (150ml); Other: Blood sample (20 ml)

Control

EXPERIMENTAL

Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology

Diagnostic Test: Urine collection (150ml)

Interventions

Urine collection (150ml) DIAGNOSTIC_TEST

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)

Case; Control

Blood sample (20 ml) OTHER

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.

Case

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead
• Vitadx: collaborator

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms; Disease

Interventions

Urine Specimen Collection; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Eschwège Pascal, MD, PhD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 9, 2021
• Study Start: December 13, 2021
• Primary Completion: December 12, 2024
• Study Completion: June 12, 2025
• Last Updated: July 24, 2025

Record last verified: 2024-12

Locations

FR (1)