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

Bladder Cancer Clinical Trial

— VISIOCYT 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966691
• Other study ID #: 2016-A00623-48
• Status: Completed
• Phase: N/A
• Start date: January 24, 2017
• Est. completion date: January 16, 2021

Study information

• Verified date: December 2021
• Source: Vitadx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1360
• Est. completion date: January 16, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital d'Antony	Antony
France	Clinique " la Châtaigneraie "	Beaumont
France	CHU de Besançon	Besançon
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Edouard Herriot	Lyon
France	Institut Paoli-Calmettes	Marseille
France	Clinique BeauSoleil	Montpellier
France	Hôtel Dieu, CHR de Nantes	Nantes
France	CHU Caremeau, Nimes	Nimes
France	Hôpital Cochin	Paris
France	CHU Rennes	Rennes
France	Hôpital Foch	Suresnes
France	Hopital Rangueil	Toulouse
France	CHRU Nancy	Vandœuvre-lès-Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Vitadx	FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE, SATT Paris Saclay

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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