<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02966691</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00623-48</org_study_id>
    <nct_id>NCT02966691</nct_id>
  </id_info>
  <brief_title>Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors</brief_title>
  <acronym>VISIOCYT 1</acronym>
  <official_title>Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vitadx</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SATT Paris Saclay</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vitadx</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study is designed to evaluate the diagnostic performance of VisioCyt test,&#xD;
      which would improve the early diagnosis of bladder cancer in order to optimize the management&#xD;
      of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of&#xD;
      VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary&#xD;
      cytology slides prepared according to the protocol VisioCyt.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is divided into two main phases:&#xD;
&#xD;
      I. The first one involves the construction of better image processing algorithm from a&#xD;
      learning sample. The learning sample will include 600 virtual slides made from the urine&#xD;
      sample of the first 600 patients enrolled.&#xD;
&#xD;
      II. The second one, will evaluate from an evaluation sample, the diagnostic performance of&#xD;
      the test VisioCyt, to identify patients with versus without bladder tumors, using as&#xD;
      comparator the results of the examination of reference: histology. The evaluation sample will&#xD;
      include 400 slides, made from the urine sample of the last 400 patients enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Actual">January 16, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification and classification of cells with the VisioCyt test to create an image processing algorithm</measure>
    <time_frame>9 months</time_frame>
    <description>* Identification and classification of cells, taking the Paris System in 2016 as a referential</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm</measure>
    <time_frame>9 months</time_frame>
    <description>presence or absence of a membrane fluorescence perished, on slides</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sensitivity of urinalysis by VisioCyt test</measure>
    <time_frame>through the study completion</time_frame>
    <description>number of patients &quot;declared positive&quot; with the VisioCyt test among the patients actually suffering from bladder carcinoma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>specificity of urinalysis by VisioCyt test</measure>
    <time_frame>through the study completion</time_frame>
    <description>number of patients &quot;declared negative&quot; with the VisioCyt test among the really healthy patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients</measure>
    <time_frame>through the study completion</time_frame>
    <description>number of patients &quot;declared positive&quot; with the VisioCyt test among the patients with a &quot;low grade&quot; or &quot;high grade&quot; bladder carcinoma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sensitivity of urinalysis by VisioCyt test according to medical history of the patients</measure>
    <time_frame>through the study completion</time_frame>
    <description>number of patients &quot;declared positive&quot; with the VisioCyt test among the patients with a first diagnosis of bladder carcinoma or among patients with a previous bladder carcinoma under monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology</measure>
    <time_frame>through the study completion</time_frame>
    <description>number of patients &quot;declared positive&quot; with the VisioCyt test versus patients &quot;declared positive&quot; with the conventional urine cytology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology</measure>
    <time_frame>through the study completion</time_frame>
    <description>number of patients &quot;declared negative&quot; with the VisioCyt test versus patients &quot;declared negative&quot; with the conventional urine cytology</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1360</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Patients 'sick'</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients of this arm have a clinical signs of bladder cancer with :&#xD;
a positive result of bladder endoscopy&#xD;
or an negative endoscopy and a positive result of the conventional cytology&#xD;
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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients 'healthy'</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients of this arm have no suspicion of bladder cancer with negative results of their bladder endoscopy and conventional cytology.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients 'monitoring'</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VisioCyt® diagnostic test</intervention_name>
    <description>The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.</description>
    <arm_group_label>Patients 'healthy'</arm_group_label>
    <arm_group_label>Patients 'monitoring'</arm_group_label>
    <arm_group_label>Patients 'sick'</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Patient affiliated to a social security system&#xD;
&#xD;
          -  Patient able to understand the protocol.&#xD;
&#xD;
          -  Signature of patient consent form before the start of the study&#xD;
&#xD;
          -  Negative urine culture&#xD;
&#xD;
          -  Patient for which is programmed a bladder Endoscopy for :&#xD;
&#xD;
               -  suspected bladder cancer (de novo, monitoring or relapse)&#xD;
&#xD;
               -  Exploration lower urinary tract excluding a suspected bladder cancer or prostate&#xD;
                  cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Ongoing Urinary tract infection untreated&#xD;
&#xD;
          -  Private person of liberty or under guardianship (including guardianship)&#xD;
&#xD;
          -  Bladder cancer excluding urothelial carcinoma&#xD;
&#xD;
          -  Carcinoma of high urinary tract, associated&#xD;
&#xD;
          -  Lithiasis pathology&#xD;
&#xD;
          -  Patient who underwent renal transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital d'Antony</name>
      <address>
        <city>Antony</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique &quot; la Châtaigneraie &quot;</name>
      <address>
        <city>Beaumont</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique BeauSoleil</name>
      <address>
        <city>Montpellier</city>
        <zip>34070</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôtel Dieu, CHR de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caremeau, Nimes</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Rangueil</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Nancy</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>October 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>December 16, 2021</last_update_submitted>
  <last_update_submitted_qc>December 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 8, 2022</submitted>
    <returned>April 12, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02966691
org study id: 2016-A00623-48
nct id: NCT02966691
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Identification and classification of cells with the VisioCyt test to create an image processing algorithm
time frame: 9 months
description: * Identification and classification of cells, taking the Paris System in 2016 as a referential
measure: Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm
time frame: 9 months
description: presence or absence of a membrane fluorescence perished, on slides
measure: sensitivity of urinalysis by VisioCyt test
time frame: through the study completion
description: number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma
measure: specificity of urinalysis by VisioCyt test
time frame: through the study completion
description: number of patients "declared negative" with the VisioCyt test among the really healthy patients
measure: sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients
time frame: through the study completion
description: number of patients "declared positive" with the VisioCyt test among the patients with a "low grade" or "high grade" bladder carcinoma
measure: sensitivity of urinalysis by VisioCyt test according to medical history of the patients
time frame: through the study completion
description: 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
measure: comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology
time frame: through the study completion
description: number of patients "declared positive" with the VisioCyt test versus patients "declared positive" with the conventional urine cytology
measure: comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology
time frame: through the study completion
description: number of patients "declared negative" with the VisioCyt test versus patients "declared negative" with the conventional urine cytology
arm group label: Patients 'sick'
arm group type: Active Comparator
description: 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
arm group label: Patients 'healthy'
arm group type: Active Comparator
description: 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.
arm group label: Patients 'monitoring'
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: VisioCyt® diagnostic test
description: The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.
arm group label: Patients 'healthy'
arm group label: Patients 'monitoring'
arm group label: Patients 'sick'
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
sharing ipd: No
submitted: February 8, 2022
returned: April 12, 2022