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

NCT ID: NCT05151341

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2025-06-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Case

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

Group Type: EXPERIMENTAL

Urine collection (150ml)

Intervention Type: 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)

Blood sample (20 ml)

Intervention Type: 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.

Control

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

Group Type: EXPERIMENTAL

Urine collection (150ml)

Intervention Type: 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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitadx

OTHER

Sponsor Role: collaborator

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eschwège Pascal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

2021-A01054-37

Identifier Type: -

Identifier Source: org_study_id