Testing a new AI-based urine test for bladder cancer detection

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

This study is testing a new urine test using AI to see if it can better detect bladder cancer in patients who are at high risk for it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vitadx (Academic / other)
• Locations: 15 sites (Anderlecht and 14 other locations)
• Trial ID: NCT05176145 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the VisioCyt® test, an innovative in vitro diagnostic device that utilizes artificial intelligence and bright-field imaging to analyze urine samples for the early detection of non-muscle invasive bladder cancer (NMIBC). The study aims to demonstrate the superiority of this test over conventional cytology in identifying tumor recurrences in patients at high risk for progression. Conducted across multiple centers in Europe, it focuses on patients who have been diagnosed with NMIBC within the last 24 months. The trial will assess the effectiveness of the VisioCyt® test in improving diagnostic accuracy and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a recent diagnosis of high or very high-risk non-muscle invasive bladder cancer under surveillance.

Not a fit: Patients who have undergone total bladder resection or have bladder cancer types other than urothelial carcinoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this test could lead to earlier and more accurate detection of bladder cancer recurrences, improving patient management and outcomes.

How similar studies have performed: Other studies have shown promise with AI-based diagnostic tools in oncology, suggesting potential for success with this novel approach.

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

Where this trial is running

Anderlecht and 14 other locations

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

Study contacts

• Study coordinator: Stéphanie Grojean, PhD

Conditions Non-muscle Invasive Bladder Cancer; NMIBC; recurrence