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/NCT06000527</url>
    </required_header>
    <id_info>
      <org_study_id>HJ-20-REPA</org_study_id>
      <nct_id>NCT06000527</nct_id>
    </id_info>
    <brief_title>Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort &quot; REPA &quot;)</brief_title>
    <acronym>REPA</acronym>
    <official_title>Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort &quot; REPA &quot;)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imagine Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imagine Institute</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>
        Recurrent respiratory papillomatosis (RRP) is a rare disease. However, it is the most common&#xD;
        benign laryngeal tumor in children. To date, no epidemiological data are available in France.&#xD;
        The aim of this study is to establish the epidemiology of juvenile PPR.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Recurrent respiratory papillomatosis (RRP) is characterized by the recurrent proliferation of&#xD;
        multiple polypoid squamous tumors in the respiratory tract, linked to HPV infection. RRP is a&#xD;
        rare disease. However, it is the most common benign laryngeal tumor in children.&#xD;
  &#xD;
        There are currently no French national epidemiological data on this disease. The data&#xD;
        collected by the reference centers will enable us to gain a better understanding of this&#xD;
        pathology in terms of epidemiology, risk factors, genetic susceptibility and clinical&#xD;
        manifestations, as well as to significantly study the efficacy of the various existing&#xD;
        therapies and preventive measures, in order to establish a clear, standardized and optimal&#xD;
        guideline.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2032</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2032</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Epidemiology of juvenile RRP in France by clinical information</measure>
      <time_frame>10 years</time_frame>
      <description>age at onset of disease, symptoms, severity score, intensity of disease characterized by need for endoscopies</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Epidemiology of juvenile PRR in France according to vaccine and adjuvant therapeutic information</measure>
      <time_frame>10 years</time_frame>
      <description>Vaccination and adjuvant therapy information</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Epidemiology of juvenile PRR in France by paraclinical information</measure>
      <time_frame>10 years</time_frame>
      <description>results of pulmonary imaging, genetic, anatomopathological and immunological tests</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Define standardized management of juvenile RRP</measure>
      <time_frame>10 years</time_frame>
      <description>Correlations between disease progression and frequency of follow-up, as well as treatments implemented (therapeutic or surgical interventions)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Therapeutic management of RRP</measure>
      <time_frame>10 years</time_frame>
      <description>Frequency of therapeutic surgery&#xD;
  Use of adjuvant therapies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevention of RRP</measure>
      <time_frame>10 years</time_frame>
      <description>Analysis of national vaccination coverage with a vaccine immunizing against HPV 6 and 11</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Juvenile Recurrent Respiratory Papillomatosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All patients with juvenile PRR in France&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with juvenile PRR (disease onset before age 18)&#xD;
  &#xD;
            -  Followed in the :&#xD;
  &#xD;
                 -  The MALO CRMR&#xD;
  &#xD;
                 -  One of the MALO network's CCMRs&#xD;
  &#xD;
                 -  One of the main correspondent centers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients objecting to the collection of their personal data&#xD;
  &#xD;
            -  Parents of minor patients objecting to the collection of their child's personal data&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nicolas LEBOULANGER, MD</last_name>
      <phone>0144494682</phone>
      <email>nicolas.leboulanger@aphp.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>hôpital Necker Enfants malades</name>
        <address>
          <city>Paris</city>
          <zip>75015</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nicolas Leboulanger</last_name>
        <phone>0144494682</phone>
        <email>nicolas.leboulanger@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Respiratory Tract Infections</mesh_term>
      <mesh_term>Papillomavirus Infections</mesh_term>
      <mesh_term>Papilloma</mesh_term>
      <mesh_term>Recurrence</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/NCT06000527
  org study id: HJ-20-REPA
  nct id: NCT06000527
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Recurrent respiratory papillomatosis (RRP) is a rare disease. However, it is the most common
        benign laryngeal tumor in children. To date, no epidemiological data are available in France.
        The aim of this study is to establish the epidemiology of juvenile PPR.
  Recurrent respiratory papillomatosis (RRP) is characterized by the recurrent proliferation of
        multiple polypoid squamous tumors in the respiratory tract, linked to HPV infection. RRP is a
        rare disease. However, it is the most common benign laryngeal tumor in children.
  
        There are currently no French national epidemiological data on this disease. The data
        collected by the reference centers will enable us to gain a better understanding of this
        pathology in terms of epidemiology, risk factors, genetic susceptibility and clinical
        manifestations, as well as to significantly study the efficacy of the various existing
        therapies and preventive measures, in order to establish a clear, standardized and optimal
        guideline.
  observational model: Cohort
  time perspective: Prospective
  measure: Epidemiology of juvenile RRP in France by clinical information
  time frame: 10 years
  description: age at onset of disease, symptoms, severity score, intensity of disease characterized by need for endoscopies
  measure: Epidemiology of juvenile PRR in France according to vaccine and adjuvant therapeutic information
  time frame: 10 years
  description: Vaccination and adjuvant therapy information
  measure: Epidemiology of juvenile PRR in France by paraclinical information
  time frame: 10 years
  description: results of pulmonary imaging, genetic, anatomopathological and immunological tests
  measure: Define standardized management of juvenile RRP
  time frame: 10 years
  description: Correlations between disease progression and frequency of follow-up, as well as treatments implemented (therapeutic or surgical interventions)
  measure: Therapeutic management of RRP
  time frame: 10 years
  description: Frequency of therapeutic surgery
  Use of adjuvant therapies
  measure: Prevention of RRP
  time frame: 10 years
  description: Analysis of national vaccination coverage with a vaccine immunizing against HPV 6 and 11
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Nicolas LEBOULANGER, MD
  phone: 0144494682
  email: nicolas.leboulanger@aphp.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Respiratory Tract Infections
  mesh term: Papillomavirus Infections
  mesh term: Papilloma
  mesh term: Recurrence