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/NCT06019221</url>
    </required_header>
    <id_info>
      <org_study_id>8783</org_study_id>
      <nct_id>NCT06019221</nct_id>
    </id_info>
    <brief_title>Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study</brief_title>
    <acronym>PRP</acronym>
    <official_title>Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study</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>
        The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015&#xD;
        study) and therefore the data on the pathology very poor, especially on the therapeutic&#xD;
        level.&#xD;
  &#xD;
        Without appropriate treatment, the disabling sequelae, even involving the vital prognosis,&#xD;
        are significant. However, in paediatrics, therapeutic habits have been extrapolated from&#xD;
        adult data and lack precision.&#xD;
  &#xD;
        Existing treatments are almost composed of immunomodulatory and/or immunosuppressive&#xD;
        treatments. Different therapeutic lines have been introduced over the years and a better&#xD;
        understanding of the pathology. More recently, biotherapies have been introduced in this&#xD;
        pathology, but data on their effectiveness remain limited. Data on the evolution under&#xD;
        therapy in children are thus still poor.&#xD;
  &#xD;
        Complications related to the pathology that can jeopardize the vital prognosis and the&#xD;
        response to treatment for this pathology deserve to be studied in order to be known and if&#xD;
        possible avoided.&#xD;
  &#xD;
        The aim of the study is to describe French practices and compare the lines of treatment&#xD;
        proposed for juvenile atrophic polychondritis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 18, 2023</start_date>
    <completion_date type="Anticipated">January 18, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 18, 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 pediatric relapsing polychondritis in France</measure>
      <time_frame>Files analysed retrospectively from from January 01, 2008 to December 31, 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 relapsing polychondritis.</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Relapsing Polychondritis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Minor subject aged 1 to 17 years having atrophic polychondritis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Minor subject aged 1 to 17 years&#xD;
  &#xD;
            -  Diagnosis of atrophic polychondritis between 01/01/2008 to 31/12/2022.&#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&#xD;
               the study&#xD;
  &#xD;
            -  Associated pathologies that cannot be related to the diagnosis of atrophic&#xD;
               polychondritis and whose prognosis can lead to biases in the efficacy and/or&#xD;
               complications related to treatments.&#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>Sarah-Louisa MAHI, MD</last_name>
      <phone>33 3 88 12 77 42</phone>
      <email>sarah-louisa.mahi@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 42</phone>
        <email>ariane.zaloszyc@chru-strasbourg.fr</email>
      </contact>
      <contact_backup>
        <last_name>Sarah-Louisa MAHI, MD</last_name>
        <phone>33 3 88 12 77 42</phone>
        <email>sarah-louisa.mahi@chru-strasbourg.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Ariane ZALOSZYC, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sarah-Louisa MAHI, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alexandre BELOT, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Johanna CLET, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yves HATCHUEL, 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>Polychondritis</keyword>
    <keyword>Relapsing Polychondritis</keyword>
    <keyword>Pediatric Relapsing Polychondritis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polychondritis, Relapsing</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/NCT06019221
  org study id: 8783
  nct id: NCT06019221
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015
        study) and therefore the data on the pathology very poor, especially on the therapeutic
        level.
  
        Without appropriate treatment, the disabling sequelae, even involving the vital prognosis,
        are significant. However, in paediatrics, therapeutic habits have been extrapolated from
        adult data and lack precision.
  
        Existing treatments are almost composed of immunomodulatory and/or immunosuppressive
        treatments. Different therapeutic lines have been introduced over the years and a better
        understanding of the pathology. More recently, biotherapies have been introduced in this
        pathology, but data on their effectiveness remain limited. Data on the evolution under
        therapy in children are thus still poor.
  
        Complications related to the pathology that can jeopardize the vital prognosis and the
        response to treatment for this pathology deserve to be studied in order to be known and if
        possible avoided.
  
        The aim of the study is to describe French practices and compare the lines of treatment
        proposed for juvenile atrophic polychondritis.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Description of the various treatments for pediatric relapsing polychondritis in France
  time frame: Files analysed retrospectively from from January 01, 2008 to December 31, 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 relapsing polychondritis.
  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: Sarah-Louisa MAHI, MD
  phone: 33 3 88 12 77 42
  email: sarah-louisa.mahi@chru-strasbourg.fr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Polychondritis, Relapsing