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

Not Applicable

Recruiting

• Conditions: Non-muscle Invasive Bladder Cancer (NMIBC)
• Interventions: Device: VisioCyt®

• Registration Number: NCT05176145
• Lead Sponsor: Vitadx

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-04
• Study Start: 2022-04-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13
• Primary Completion: 2025-02-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	VisioCyt®	Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology

Primary Outcome Measures

Name	Time	Method
Performance of VisioCyt® test vs conventional cytology	24 months	Sensibility of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined

Secondary Outcome Measures

Name	Time	Method
Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology	24 months	Specificity of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined

Trial Locations

Locations (15)

CHU de Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

Hôpital Académique ERASME; 🇧🇪 Anderlecht, Belgium

CHU de Caen; 🇫🇷 Caen, France

CHU Angers; 🇫🇷 Angers, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Grenoble; 🇫🇷 Grenoble, 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 Tours; 🇫🇷 Tours, France

CHU Toulouse; 🇫🇷 Toulouse, France

Pr Maria Jose Ribal; 🇪🇸 Barcelona, Spain