<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/NCT02212249</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00186-41</org_study_id>
    <nct_id>NCT02212249</nct_id>
  </id_info>
  <brief_title>Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis</brief_title>
  <acronym>Sclerocadh1</acronym>
  <official_title>Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune&#xD;
      disease with a endothelial dysfunction. This study is to evaluated the level of soluble&#xD;
      VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of soluble Ve-cadherin and antibody VE-cadherin with ELISA TEST in Scleroderma group versus Primary Raynaud's Phenomenon</measure>
    <time_frame>At 30 days average</time_frame>
    <description>Level of human sVE and antibody VE-cadherin in blood will be determined by ELISA test in both groups Scleroderma and Primary Raynaud's Phenomenon.&#xD;
The methodology of dosage of sVE is based on the pattern:WO/2008/062314 The methodolody of the dosage of antibody VE-cadherin is based on the pattern WO/2012/136820 .&#xD;
Group Scleroderma (N=60) versus Primary Raynaud's Phenomenon (N=20). Shapiro test.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Primary Raynaud Disease</condition>
  <condition>Systemic Sclerosis</condition>
  <arm_group>
    <arm_group_label>Systemic sclerosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with systemic sclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>primary raynaud disease</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patients with primary raynaud disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>soluble Ve cadherin</intervention_name>
    <description>dosage of soluble VE cadherine in each arms</description>
    <arm_group_label>Systemic sclerosis</arm_group_label>
    <arm_group_label>primary raynaud disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  group 1: systemic sclerosis&#xD;
&#xD;
          -  group 2: raynaud primary disease&#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>Grenoble University Hospital</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>April 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>March 23, 2016</last_update_submitted>
  <last_update_submitted_qc>March 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>soluble VE-cadherin</keyword>
  <keyword>antibody</keyword>
  <keyword>systemic slerosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Raynaud Disease</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</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/NCT02212249
org study id: 2014-A00186-41
nct id: NCT02212249
lead sponsor: 
has dmc: No
Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune
      disease with a endothelial dysfunction. This study is to evaluated the level of soluble
      VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Level of soluble Ve-cadherin and antibody VE-cadherin with ELISA TEST in Scleroderma group versus Primary Raynaud's Phenomenon
time frame: At 30 days average
description: Level of human sVE and antibody VE-cadherin in blood will be determined by ELISA test in both groups Scleroderma and Primary Raynaud's Phenomenon.
The methodology of dosage of sVE is based on the pattern:WO/2008/062314 The methodolody of the dosage of antibody VE-cadherin is based on the pattern WO/2012/136820 .
Group Scleroderma (N=60) versus Primary Raynaud's Phenomenon (N=20). Shapiro test.
arm group label: Systemic sclerosis
arm group type: Active Comparator
description: patients with systemic sclerosis
arm group label: primary raynaud disease
arm group type: Sham Comparator
description: patients with primary raynaud disease
intervention type: Biological
intervention name: soluble Ve cadherin
description: dosage of soluble VE cadherine in each arms
arm group label: Systemic sclerosis
arm group label: primary raynaud disease
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Raynaud Disease
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis