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

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Bladder Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05151341

2021-A01054-37

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Case

Experimental group

Description:

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

Treatment:

Diagnostic Test: Urine collection (150ml)

Other: Blood sample (20 ml)

Control

Experimental group

Description:

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

Treatment:

Diagnostic Test: Urine collection (150ml)