NCT02966691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 24, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2021

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

3.9 years

First QC Date

October 28, 2016

Last Update Submit

December 16, 2021

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients

    through the study completion

  • sensitivity of urinalysis by VisioCyt test according to medical history of the patients

    through the study completion

  • comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology

    through the study completion

  • comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology

    through the study completion

Study Arms (3)

Patients 'sick'

ACTIVE COMPARATOR

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

Patients 'healthy'

ACTIVE COMPARATOR

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

Patients 'monitoring'

ACTIVE COMPARATOR

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

Interventions

VisioCyt® diagnostic testOTHER

The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.

Patients 'healthy'Patients 'monitoring'Patients 'sick'

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hôpital d'Antony

Antony, France

Location

Clinique " la Châtaigneraie "

Beaumont, France

Location

CHU de Besançon

Besançon, 25000, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Clinique BeauSoleil

Montpellier, 34070, France

Location

Hôtel Dieu, CHR de Nantes

Nantes, 44093, France

Location

CHU Caremeau, Nimes

Nîmes, 30029, France

Location

Hôpital Cochin

Paris, France

Location

CHU Rennes

Rennes, 35033, France

Location

Hôpital Foch

Suresnes, France

Location

Hopital Rangueil

Toulouse, France

Location

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 17, 2016

Study Start

January 24, 2017

Primary Completion

December 31, 2020

Study Completion

January 16, 2021

Last Updated

January 6, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(14)