<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/NCT01713504</url>
  </required_header>
  <id_info>
    <org_study_id>2008_29</org_study_id>
    <secondary_id>2009-A00314-53</secondary_id>
    <nct_id>NCT01713504</nct_id>
  </id_info>
  <brief_title>Identification of New Markers in the Hypereosinophilic Syndrome</brief_title>
  <acronym>SHE</acronym>
  <official_title>Identification of New Markers in the Hypereosinophilic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and&#xD;
      more accessible compared to those that we have already thanks to a proteomic approach. This&#xD;
      will help the investigators to diagnose the this disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2010</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia.</measure>
    <time_frame>one month after patient inclusion</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Hypereosinophilic Syndrome</condition>
  <arm_group>
    <arm_group_label>Hypereosinophilic syndrome unexplained</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypereosinophilic syndrome explained</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal rate of eosinophilic</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>biologie sample</intervention_name>
    <description>comparison of biomarkers between HES, HE biomarkers data and control arms</description>
    <arm_group_label>Hypereosinophilic syndrome explained</arm_group_label>
    <arm_group_label>Hypereosinophilic syndrome unexplained</arm_group_label>
    <arm_group_label>Normal rate of eosinophilic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  dated and signed informed consent&#xD;
&#xD;
          -  virale serology negative or negative result less than 6 months&#xD;
&#xD;
          -  virale serology negative for HBV or vaccinated patient&#xD;
&#xD;
          -  insured&#xD;
&#xD;
          -  virale serology negative or negative result less than 6 months&#xD;
&#xD;
          -  negative pregnancy test or female menopause for at least 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subject enable adult, under guardianship or under protective measures of justice&#xD;
&#xD;
          -  Refusal or inability to give informed consent&#xD;
&#xD;
          -  The hypereosinophilic syndrome explained origin other than than atopy, bullous&#xD;
             pemphigoid, the Churg-Strauss syndrome and DRESS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lionel Prin, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU, Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <state>Nord</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</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>Hypereosinophilic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01713504
org study id: 2008_29
secondary id: 2009-A00314-53
nct id: NCT01713504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and
      more accessible compared to those that we have already thanks to a proteomic approach. This
      will help the investigators to diagnose the this disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia.
time frame: one month after patient inclusion
arm group label: Hypereosinophilic syndrome unexplained
arm group type: Experimental
arm group label: Hypereosinophilic syndrome explained
arm group type: Active Comparator
arm group label: Normal rate of eosinophilic
arm group type: Sham Comparator
intervention type: Biological
intervention name: biologie sample
description: comparison of biomarkers between HES, HE biomarkers data and control arms
arm group label: Hypereosinophilic syndrome explained
arm group label: Hypereosinophilic syndrome unexplained
arm group label: Normal rate of eosinophilic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lionel Prin, MD PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Hypereosinophilic Syndrome
mesh term: Syndrome
sharing ipd: No