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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VisioCyt® diagnostic test
Sponsored by
Vitadx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital d'Antony
  • Clinique " la Châtaigneraie "
  • CHU de Besançon
  • CHU de Clermont-Ferrand
  • Hôpital Edouard Herriot
  • Institut Paoli-Calmettes
  • Clinique BeauSoleil
  • Hôtel Dieu, CHR de Nantes
  • CHU Caremeau, Nimes
  • Hôpital Cochin
  • CHU Rennes
  • Hôpital Foch
  • Hopital Rangueil
  • CHRU Nancy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Patients 'sick'

Patients 'healthy'

Patients 'monitoring'

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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
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
sensitivity of urinalysis by VisioCyt test
number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma
specificity of urinalysis by VisioCyt test
number of patients "declared negative" with the VisioCyt test among the really healthy patients

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
October 28, 2016
Last Updated
December 16, 2021
Sponsor
Vitadx
Collaborators
FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE, SATT Paris Saclay
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1. Study Identification

Unique Protocol Identification Number
NCT02966691
Brief Title
Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors
Acronym
VISIOCYT 1
Official Title
Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitadx
Collaborators
FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE, SATT Paris Saclay

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients 'sick'
Arm Type
Active Comparator
Arm Description
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
Arm Title
Patients 'healthy'
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patients 'monitoring'
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
VisioCyt® diagnostic test
Intervention Description
The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.
Primary Outcome Measure Information:
Title
Identification and classification of cells with the VisioCyt test to create an image processing algorithm
Description
* Identification and classification of cells, taking the Paris System in 2016 as a referential
Time Frame
9 months
Title
Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm
Description
presence or absence of a membrane fluorescence perished, on slides
Time Frame
9 months
Title
sensitivity of urinalysis by VisioCyt test
Description
number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma
Time Frame
through the study completion
Title
specificity of urinalysis by VisioCyt test
Description
number of patients "declared negative" with the VisioCyt test among the really healthy patients
Time Frame
through the study completion
Secondary Outcome Measure Information:
Title
sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients
Description
number of patients "declared positive" with the VisioCyt test among the patients with a "low grade" or "high grade" bladder carcinoma
Time Frame
through the study completion
Title
sensitivity of urinalysis by VisioCyt test according to medical history of the patients
Description
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
Time Frame
through the study completion
Title
comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology
Description
number of patients "declared positive" with the VisioCyt test versus patients "declared positive" with the conventional urine cytology
Time Frame
through the study completion
Title
comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology
Description
number of patients "declared negative" with the VisioCyt test versus patients "declared negative" with the conventional urine cytology
Time Frame
through the study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital d'Antony
City
Antony
Country
France
Facility Name
Clinique " la Châtaigneraie "
City
Beaumont
Country
France
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Clinique BeauSoleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Hôtel Dieu, CHR de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Caremeau, Nimes
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital Foch
City
Suresnes
Country
France
Facility Name
Hopital Rangueil
City
Toulouse
Country
France
Facility Name
CHRU Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors

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