<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/NCT01723631</url>
  </required_header>
  <id_info>
    <org_study_id>BRD/10/06-S</org_study_id>
    <secondary_id>2010-A00892-37</secondary_id>
    <nct_id>NCT01723631</nct_id>
  </id_info>
  <brief_title>Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis</brief_title>
  <acronym>TRAP-Myéline</acronym>
  <official_title>Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this project is to characterize the response TRAP positive patients with&#xD;
      Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in&#xD;
      order to develop a second time as a diagnostic tool in this disease. We plan to analyze the&#xD;
      response TRAP over a hundred patients with various clinical stages SEP (relapsing,&#xD;
      progressive forms) and compared to healthy controls,&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The number of patients achieved is sufficient to evaluate the diagnostic performance of the&#xD;
    test TRAP-myelin&#xD;
  </why_stopped>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis</measure>
    <time_frame>2 years</time_frame>
    <description>The main criterion corresponds to the area under the curve ROC (Receiver operating characteristic). The curve ROC is a graphic representation of the existing relation between the sensibility and the specificity of a test, calculated for all the values possible thresholds. The performance of the test TRAP-myéline will thus be estimated by means of the area calculated under this curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">189</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Relapsing Multiple Sclerosis- group 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relapsing Multiple Sclerosis- group 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>secondary progressive multiple sclerosis- Group 3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>primary progressive multiple sclerosis- group 4</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with central or peripheral neurological non-inflammatory, non-autoimmune.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients having an autoimmune pathology</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trap Myelin Test</intervention_name>
    <arm_group_label>Control 2</arm_group_label>
    <arm_group_label>Control 3</arm_group_label>
    <arm_group_label>Relapsing Multiple Sclerosis- group 1</arm_group_label>
    <arm_group_label>Relapsing Multiple Sclerosis- group 2</arm_group_label>
    <arm_group_label>control 1</arm_group_label>
    <arm_group_label>primary progressive multiple sclerosis- group 4</arm_group_label>
    <arm_group_label>secondary progressive multiple sclerosis- Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  These criteria depend on the subgroup belongs to the patient.&#xD;
&#xD;
          -  Signed consent&#xD;
&#xD;
          -  Membership of a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Whatever the patient group or control:&#xD;
&#xD;
          -  Processing immunosuppressive.&#xD;
&#xD;
          -  Processing by a monoclonal antibody.&#xD;
&#xD;
          -  Previous treatment with an immunosuppressant for a significant period of time (more&#xD;
             than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures&#xD;
             mitoxantrone).&#xD;
&#xD;
          -  Carcinomatous pathology known evolving.&#xD;
&#xD;
          -  People under guardianship.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Patients not motivated to study. Known patients with anemia (hemoglobin &lt;10g/100ml)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital neurologigue Pierre Wertheimer</name>
      <address>
        <city>Bron</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of clermont Ferrand</name>
      <address>
        <city>Clermont Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Nice</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple sclerosis</keyword>
  <keyword>TRAP</keyword>
  <keyword>TRAP-Myéline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01723631
org study id: BRD/10/06-S
secondary id: 2010-A00892-37
nct id: NCT01723631
lead sponsor: 
collaborator: 
has dmc: No
The objective of this project is to characterize the response TRAP positive patients with
      Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in
      order to develop a second time as a diagnostic tool in this disease. We plan to analyze the
      response TRAP over a hundred patients with various clinical stages SEP (relapsing,
      progressive forms) and compared to healthy controls,
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis
time frame: 2 years
description: The main criterion corresponds to the area under the curve ROC (Receiver operating characteristic). The curve ROC is a graphic representation of the existing relation between the sensibility and the specificity of a test, calculated for all the values possible thresholds. The performance of the test TRAP-myéline will thus be estimated by means of the area calculated under this curve
measure: Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated
time frame: 2 years
arm group label: Relapsing Multiple Sclerosis- group 1
arm group type: Other
description: Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months.
arm group label: Relapsing Multiple Sclerosis- group 2
arm group type: Other
description: Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months.
arm group label: secondary progressive multiple sclerosis- Group 3
arm group type: Other
description: Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis
arm group label: primary progressive multiple sclerosis- group 4
arm group type: Other
description: Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis
arm group label: control 1
arm group type: Other
description: healthy volunteers
arm group label: Control 2
arm group type: Other
description: Patients with central or peripheral neurological non-inflammatory, non-autoimmune.
arm group label: Control 3
arm group type: Other
description: Patients having an autoimmune pathology
intervention type: Device
intervention name: Trap Myelin Test
arm group label: Control 2
arm group label: Control 3
arm group label: Relapsing Multiple Sclerosis- group 1
arm group label: Relapsing Multiple Sclerosis- group 2
arm group label: control 1
arm group label: primary progressive multiple sclerosis- group 4
arm group label: secondary progressive multiple sclerosis- Group 3
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis