Clinical trial NCT05176145: Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test
Official title: Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-muscle Invasive Bladder Cancer (NMIBC)
Keywords: NMIBC
recurrence
Lead sponsor: Vitadx
Sponsor class: OTHER
Collaborators: name: FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE
First posted: 2022-01-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Performance of VisioCyt® test vs conventional cytology
timeFrame: 24 months
Secondary outcomes:
measure: Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology
timeFrame: 24 months
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Hôpital Académique ERASME
city: Angers
country: France
facility: CHU Angers
city: Caen
country: France
facility: CHU de Caen
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard,
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière, APHP
city: Quint Fonsegrives
country: France
facility: Clinique la Croix du Sud
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Suresnes
country: France
facility: Hopital Foch
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Barcelona
country: Spain
facility: Pr Maria Jose Ribal
Study officials:
References: