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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Non-muscle Invasive Bladder Cancer (NMIBC)

Intervention / Treatment
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* Device: VisioCyt®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm<br>Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology | Device: VisioCyt®<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMIBC, recurrence