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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-24

Study Completion Date

2021-01-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

VisioCyt® diagnostic test

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

VisioCyt® diagnostic test

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

VisioCyt® diagnostic test

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No