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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Stéphanie Grojean, PhD
• Email: DMIA@fondation-force.fr
• Phone: 33 (0)383501921

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Alpha1H before bladder tumor surgery in low/intermediate risk non-muscle-invasive bladder cancer

  This trial tests whether putting Alpha1H directly into the bladder before standard surgery helps prevent cancer from coming back or getting worse in adults with low- to intermediate-risk non-muscle-invasive bladder cancer.

  Recruiting Phase 3 Hamlet Pharma AB · Prague · NCT07804056

• Active surveillance versus single-dose intravesical chemo after TURBT in low-shedding intermediate-risk NMIBC

  This study tests whether some patients with intermediate-risk non-muscle-invasive bladder cancer can skip additional bladder chemotherapy after complete tumor removal if urine tests show a low-shedding profile.

  Recruiting at 5 sites Tianjin Medical University Second Hospital · Daqing and 4 other locations · NCT07749924

• LCS103 Herbal Formula for Preventing NMIBC Recurrence

  This study tests whether the LCS103 herbal formula added to standard care can help prevent bladder cancer recurrence in adults with non-muscle invasive bladder cancer.

  Recruiting LifeBiotic Medical Research Ltd. · Haifa · NCT07728474

• Intravesical UGN-501 for Recurrent NMIBC (Phase 1, dose-escalation)

  This study tests whether UGN-501 can be safely given into the bladder to treat adults with recurrent non-muscle invasive bladder cancer.

  Recruiting at 6 sites Phase 1 UroGen Pharma Ltd. · Queen Creek, Arizona and 14 other locations · NCT07725796

• Disitamab Vedotin plus Mitomycin C for HER2-positive high-risk NMIBC

  This study tests whether giving disitamab vedotin through the bloodstream together with bladder-delivered mitomycin C can help people with HER2-expressing, high-risk non-muscle-invasive bladder cancer.

  Recruiting Phase 2 Shanxi Province Cancer Hospital · Taiyuan, Shanxi · NCT07646145

• Sexual health support after bladder cancer treatment

  This project will try sexological support to help adults about 12 months after bladder cancer treatment improve sexual function and intimacy.

  Recruiting University of Aarhus · Aarhus · NCT07339761

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.