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NCT Number: NCT02966691

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

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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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital d'Antony, Antony, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VisioCyt® diagnostic test

Other

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

Primary outcomes

  1. Identification and classification of cells with the VisioCyt test to create an image processing algorithm

    Time frame: 9 months

    • Identification and classification of cells, taking the Paris System in 2016 as a referential

  2. Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm

    Time frame: 9 months

    presence or absence of a membrane fluorescence perished, on slides

  3. sensitivity of urinalysis by VisioCyt test

    Time frame: through the study completion

    number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma

  4. specificity of urinalysis by VisioCyt test

    Time frame: through the study completion

    number of patients "declared negative" with the VisioCyt test among the really healthy patients

Secondary outcomes

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

    Time frame: through the study completion

    number of patients "declared positive" with the VisioCyt test among the patients with a "low grade" or "high grade" bladder carcinoma

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

    Time frame: through the study completion

    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

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

    Time frame: through the study completion

    number of patients "declared positive" with the VisioCyt test versus patients "declared positive" with the conventional urine cytology

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

    Time frame: through the study completion

    number of patients "declared negative" with the VisioCyt test versus patients "declared negative" with the conventional urine cytology

Sponsors and collaborators

Lead sponsor

Vitadx

Other

Collaborators

  • FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE
  • SATT Paris Saclay

Registry information

Acronym: VISIOCYT 1

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Nov 17, 2016
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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