xml: <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/NCT06019234</url>
    </required_header>
    <id_info>
      <org_study_id>9028</org_study_id>
      <nct_id>NCT06019234</nct_id>
    </id_info>
    <brief_title>Juvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort</brief_title>
    <acronym>JSSc</acronym>
    <official_title>Uvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Strasbourg, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Strasbourg, France</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>
        Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic&#xD;
        sclerosis. It is a rare autoimmune pathology in pediatrics.&#xD;
  &#xD;
        The incidence in pediatrics is very low (about 4 per million according to an American) and&#xD;
        therefore the data on the pathology very poor, especially on the therapeutic level.&#xD;
  &#xD;
        The proposed immunosuppressive treatments are extrapolated from data in adults. The evolution&#xD;
        of connectivity does not seem quite identical to the evolution of adult scleroderma,&#xD;
        adaptation of treatments seems judicious. However, data on the evolution under therapy in&#xD;
        children are still poor.&#xD;
  &#xD;
        Complications related to the pathology, iatrogeny and diagnostic delay are the first causes&#xD;
        of mortality from this pathology and deserve to be studied and if possible avoided.&#xD;
  &#xD;
        The main hypothesis of the research being to bring together the experiences of the various&#xD;
        reference and competence centers in France concerning the clinical presentation, management&#xD;
        and follow-up of children with systemic sclerosis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 3, 2023</start_date>
    <completion_date type="Anticipated">October 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 3, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Description of the various treatments for juvenile systemic sclerosis in France</measure>
      <time_frame>Files analysed retrospectively from January 01, 2012 to June 30, 2022 will be examined</time_frame>
      <description>The aim of this study is to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.</description>
    </primary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Juvenile Systemic Sclerosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Minor subject (&lt;18 years old) having a systemic sclerosis between 01/01/2012 and&#xD;
          30/06/2022.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Minor subject (&lt;18 years old)&#xD;
  &#xD;
            -  Diagnosis of systemic sclerosis between 01/01/2012 and 30/06/2022.&#xD;
  &#xD;
            -  Subject (and/or his parental authority) who has not expressed, after being informed,&#xD;
               his opposition to the reuse of his data for the purposes of this research.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          - Subject (or his parents) having expressed his (their) opposition to participating in the&#xD;
          study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ariane ZALOSZYC, MD</last_name>
      <role>Study Director</role>
      <affiliation>University Hospitals of Strasbourg</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ariane ZALOSZYC, MD</last_name>
      <phone>33 3 88 12 77 42</phone>
      <email>ariane.zaloszyc@chru-strasbourg.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rouba BECHARA, MD</last_name>
      <phone>33 3 88 12 77 42</phone>
      <email>Rouba.bechara@chru-strasbourg.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Service de Pédiatrie 1 - CHU de Strasbourg - France</name>
        <address>
          <city>Strasbourg</city>
          <zip>67091</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ariane ZALOSZYC, MD</last_name>
        <phone>33 3 88 12 77 49</phone>
        <email>ariane.zaloszyc@chru-strasbourg.fr</email>
      </contact>
      <contact_backup>
        <last_name>Rouba BECHARA, MD</last_name>
        <phone>33 3 88 12 77 49</phone>
        <email>Rouba.bechara@chru-strasbourg.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Ariane ZALOSZYC, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rouba BECHARA, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Léa JACQUEL, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Anne Cécile RAMEAU, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Linda ROSSI, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Meizner ULRICH, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Irène LEMELLE, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Charlotte REBELLE, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pascal PILLET, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pauline CHOQUET, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Systemic Sclerosis</keyword>
    <keyword>Juvenile Systemic Sclerosis</keyword>
    <keyword>Immunosuppressive treatments</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
  
  
text: 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/NCT06019234
  org study id: 9028
  nct id: NCT06019234
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic
        sclerosis. It is a rare autoimmune pathology in pediatrics.
  
        The incidence in pediatrics is very low (about 4 per million according to an American) and
        therefore the data on the pathology very poor, especially on the therapeutic level.
  
        The proposed immunosuppressive treatments are extrapolated from data in adults. The evolution
        of connectivity does not seem quite identical to the evolution of adult scleroderma,
        adaptation of treatments seems judicious. However, data on the evolution under therapy in
        children are still poor.
  
        Complications related to the pathology, iatrogeny and diagnostic delay are the first causes
        of mortality from this pathology and deserve to be studied and if possible avoided.
  
        The main hypothesis of the research being to bring together the experiences of the various
        reference and competence centers in France concerning the clinical presentation, management
        and follow-up of children with systemic sclerosis.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Description of the various treatments for juvenile systemic sclerosis in France
  time frame: Files analysed retrospectively from January 01, 2012 to June 30, 2022 will be examined
  description: The aim of this study is to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 17 Years
  healthy volunteers: No
  last name: Ariane ZALOSZYC, MD
  role: Study Director
  affiliation: University Hospitals of Strasbourg
  last name: Ariane ZALOSZYC, MD
  phone: 33 3 88 12 77 42
  email: ariane.zaloszyc@chru-strasbourg.fr
  last name: Rouba BECHARA, MD
  phone: 33 3 88 12 77 42
  email: Rouba.bechara@chru-strasbourg.fr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Scleroderma, Systemic
  mesh term: Scleroderma, Diffuse
  mesh term: Sclerosis