Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test (DMIA)

October 12, 2023 updated by: Vitadx
European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Hôpital Académique ERASME
        • Contact:
          • Thierry ROUMEGUERE, Pr
  • France
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • Pierre BIGOT
      • Caen, France, 14000
        • Recruiting
        • CHU de Caen
        • Contact:
          • Xavier TILLOU, Pr
      • Clermont Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont Ferrand
        • Contact:
          • Laurent GUY, Pr
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
        • Contact:
          • Clément Sarrazin, Pr
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • Jérôme Rigaud, Pr
      • Paris, France
        • Recruiting
        • Hôpital Bichat-Claude Bernard,
        • Contact:
          • Evanguelos Xylinas, Pr
      • Paris, France
        • Recruiting
        • Hôpital Pitié-Salpêtrière, APHP
        • Contact:
          • Rouprêt Morgan, Pr
      • Quint Fonsegrives, France, 31130
        • Recruiting
        • Clinique La Croix Du Sud
        • Contact:
          • Benjamin Pradere, Pr
      • Rennes, France
        • Recruiting
        • CHU de Rennes
        • Contact:
          • Grégory Verhoest, Dr
      • Strasbourg, France
        • Recruiting
        • CHU Strasbourg
        • Contact:
          • Hervé LANG, Pr
      • Suresnes, France
        • Recruiting
        • Hopital Foch
        • Contact:
          • Thierry Lebret, Pr
      • Toulouse, France
        • Recruiting
        • CHU Toulouse
        • Contact:
          • Mathieu Roumiguié, Dr
      • Tours, France
        • Recruiting
        • CHU Tours
        • Contact:
          • Franck BRUYERE, Pr
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Pr Maria Jose Ribal
        • Contact:
          • Maria Jose Ribal, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of VisioCyt® test vs conventional cytology
Time Frame: 24 months
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
Time Frame: 24 months
Specificity of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitadx

Collaborators

FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMIA-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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