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

Bladder Cancer Clinical Trial

— URODX-FGFR3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151341
• Other study ID #: 2021-A01054-37
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Institut de Cancérologie de Lorraine
• Contact: MERLIN Jean-Louis, PU PH
• Phone: 03 83 65 60 62
• Email: jl.merlin[@]nancy.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine	Vitadx

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity	Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own	at inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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