Clinical trial NCT05151341: Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors
Official title: Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: FGFR3
VisioCyt
Bladder Tumor
Cancer
FGFR3 Mutation
Diagnosis
Cytoloogy
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
Collaborators: name: Vitadx
First posted: 2021-12-09
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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 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

Primary outcomes:
measure: Specificity
timeFrame: at inclusion
Secondary outcomes:
measure: Sensitivity of the 4 different tests
timeFrame: at inclusion
measure: Specificity of the 4 different tests
timeFrame: at inclusion
measure: Positive predictive value of the 4 different tests
timeFrame: at inclusion
measure: Negative predictive value of the 4 different tests
timeFrame: at inclusion
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Eschwège Pascal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: