Clinical trial NCT02966691: Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors
Official title: Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Vitadx
Sponsor class: OTHER
Collaborators: name: FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE
name: SATT Paris Saclay
First posted: 2016-11-17
Enrollment: 1360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Identification and classification of cells with the VisioCyt test to create an image processing algorithm
timeFrame: 9 months
measure: Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm
timeFrame: 9 months
measure: sensitivity of urinalysis by VisioCyt test
timeFrame: through the study completion
measure: specificity of urinalysis by VisioCyt test
timeFrame: through the study completion
Secondary outcomes:
measure: sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients
timeFrame: through the study completion
measure: sensitivity of urinalysis by VisioCyt test according to medical history of the patients
timeFrame: through the study completion
measure: comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology
timeFrame: through the study completion
measure: comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology
timeFrame: through the study completion
Other outcomes:
Locations:
city: Antony
country: France
facility: Hôpital d'Antony
city: Beaumont
country: France
facility: Clinique " la Châtaigneraie "
city: Besançon
country: France
facility: CHU de Besançon
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier
country: France
facility: Clinique BeauSoleil
city: Nantes
country: France
facility: Hôtel Dieu, CHR de Nantes
city: Nimes
country: France
facility: CHU Caremeau, Nimes
city: Paris
country: France
facility: Hôpital Cochin
city: Rennes
country: France
facility: CHU Rennes
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Hopital Rangueil
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
Study officials:
References: