Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test

Non-muscle Invasive Bladder Cancer (NMIBC) Clinical Trial

— DMIA  

Official title:

Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176145
• Other study ID #: DMIA-2021
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: October 2023
• Source: Vitadx
• Contact: Stéphanie Grojean, PhD
• Phone: 33 (0)383501921
• Email: DMIA[@]fondation-force.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.

Description:

VisioCyt® is based on a patented technology, combining bright-field imaging and artificial intelligence, from a simple urine sample from which the cells are extracted .

The main objective of the study is to demonstrate the medical superiority of the VisioCyt® test versus conventional cytology for detecting recurrence of bladder tumors, in patients monitoring non-muscle infiltrating bladder tumors at high and very high risk of progression

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 31, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years old and autonomous

• Patient understanding national language well and able to understand the protocol.

• Patient information and informed consent signature before the start of the study

• Patients under surveillance of Non-muscle invasive bladder cancer (NMIBC) at high and very high risk of progression, whatever the stage on the basis of a histological result. The diagnosis (primary or recurrence) should be less than or equal to 24 months (the last histology result confirming a bladder cancer with high or very high risk of recurrence is taken into account).

Exclusion Criteria:

• Patients who have had total bladder resection or bladder reconstruction

• Age <18 years old

• Person deprived of liberty or under guardianship (including curatorship)

• Bladder cancer outside of urothelial carcinoma

• Associated high urinary tract carcinoma

• Kidney transplant patient (BK virus)

• Pelvic radiotherapy patient (prostate cancer)

• Patients with or under surveillance of a muscle-infiltrating bladder tumor

Related Conditions & MeSH terms

• Non-muscle Invasive Bladder Cancer (NMIBC)

Intervention

Device:
• VisioCyt®
Cytological and endoscopic examination is planned as part of the usual management of patients under surveillance of Non-muscle invasive bladder cancer (NMIBC), according to the CCAFU guidelines. Urine collection for conventional cytology and VisioCyt® test

Locations

Country	Name	City	State
Belgium	Hôpital Académique ERASME	Anderlecht
France	CHU Angers	Angers
France	CHU de Caen	Caen
France	CHU de Clermont Ferrand	Clermont Ferrand
France	CHU Grenoble	Grenoble
France	CHU Nantes	Nantes
France	Hôpital Bichat-Claude Bernard,	Paris
France	Hôpital Pitié-Salpétrière, APHP	Paris
France	Clinique la Croix du Sud	Quint Fonsegrives
France	CHU de Rennes	Rennes
France	CHU Strasbourg	Strasbourg
France	Hopital Foch	Suresnes
France	CHU Toulouse	Toulouse
France	CHU Tours	Tours
Spain	Pr Maria Jose Ribal	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Vitadx	FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE

Countries where clinical trial is conducted

Belgium,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of VisioCyt® test vs conventional cytology	Sensibility of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined	24 months
Secondary	Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology	Specificity of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined	24 months