Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors (VISIOCYT 1)

This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: VisioCyt® diagnostic test

Detailed Description

This clinical trial is divided into two main phases:

I. The first one involves the construction of better image processing algorithm from a learning sample. The learning sample will include 600 virtual slides made from the urine sample of the first 600 patients enrolled.

II. The second one, will evaluate from an evaluation sample, the diagnostic performance of the test VisioCyt, to identify patients with versus without bladder tumors, using as comparator the results of the examination of reference: histology. The evaluation sample will include 400 slides, made from the urine sample of the last 400 patients enrolled.

• Study Type: Interventional
• Enrollment (Actual): 1360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Antony, France
    • Hôpital d'Antony
  • Beaumont, France
    • Clinique " la Châtaigneraie "
  • Besançon, France, 25000
    • CHU de Besançon
  • Clermont-Ferrand, France
    • CHU de Clermont-Ferrand
  • Lyon, France
    • Hôpital Edouard Herriot
  • Marseille, France, 13009
    • Institut Paoli-Calmettes
  • Montpellier, France, 34070
    • Clinique Beausoleil
  • Nantes, France, 44093
    • Hôtel Dieu, CHR de Nantes
  • Nimes, France, 30029
    • CHU Caremeau, Nimes
  • Paris, France
    • Hôpital Cochin
  • Rennes, France, 35033
    • CHU Rennes
  • Suresnes, France
    • Hôpital Foch
  • Toulouse, France
    • Hopital Rangueil
  • Vandœuvre-lès-Nancy, France, 54500
    • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥18 years
• Patient affiliated to a social security system
• Patient able to understand the protocol.
• Signature of patient consent form before the start of the study
• Negative urine culture

• Patient for which is programmed a bladder Endoscopy for :

  • suspected bladder cancer (de novo, monitoring or relapse)
  • Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer

Exclusion Criteria:

• Age <18 years
• Ongoing Urinary tract infection untreated
• Private person of liberty or under guardianship (including guardianship)
• Bladder cancer excluding urothelial carcinoma
• Carcinoma of high urinary tract, associated
• Lithiasis pathology
• Patient who underwent renal transplantation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients 'sick'; The patients of this arm have a clinical signs of bladder cancer with : a positive result of bladder endoscopy; or an negative endoscopy and a positive result of the conventional cytology The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice .This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized	Other: VisioCyt® diagnostic test; The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.
Active Comparator: Patients 'healthy'; The patients of this arm have no suspicion of bladder cancer with negative results of their bladder endoscopy and conventional cytology. The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized.	Other: VisioCyt® diagnostic test; The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.
Active Comparator: Patients 'monitoring'; The patients of this arm have a history of bladder cancer, but the results of their follow up examinations (cytologic and endoscopic) are negative (no tumor). The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized.	Other: VisioCyt® diagnostic test; The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification and classification of cells with the VisioCyt test to create an image processing algorithm	* Identification and classification of cells, taking the Paris System in 2016 as a referential	9 months
Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm	presence or absence of a membrane fluorescence perished, on slides	9 months
sensitivity of urinalysis by VisioCyt test	number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma	through the study completion
specificity of urinalysis by VisioCyt test	number of patients "declared negative" with the VisioCyt test among the really healthy patients	through the study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients	number of patients "declared positive" with the VisioCyt test among the patients with a "low grade" or "high grade" bladder carcinoma	through the study completion
sensitivity of urinalysis by VisioCyt test according to medical history of the patients	number of patients "declared positive" with the VisioCyt test among the patients with a first diagnosis of bladder carcinoma or among patients with a previous bladder carcinoma under monitoring	through the study completion
comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology	number of patients "declared positive" with the VisioCyt test versus patients "declared positive" with the conventional urine cytology	through the study completion
comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology	number of patients "declared negative" with the VisioCyt test versus patients "declared negative" with the conventional urine cytology	through the study completion

Collaborators and Investigators

• Sponsor: Vitadx
• Collaborators: FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE; SATT Paris Saclay

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 16, 2021

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2016-A00623-48

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
• product manufactured in and exported from the U.S.: No