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/NCT06036719</url>
    </required_header>
    <id_info>
      <org_study_id>C20-58</org_study_id>
      <secondary_id>2021-A00094-37</secondary_id>
      <nct_id>NCT06036719</nct_id>
    </id_info>
    <brief_title>Interstitial Lung Disease: A Study From Infancy to Elderly Including Relatives</brief_title>
    <acronym>RaDiCo-ILD 2</acronym>
    <official_title>Interstitial Lung Disease: A Study From Infancy to Elderly Including Relatives</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut National de la Santé Et de la Recherche Médicale, 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 concerned patients are children and adults suffering from idiopathic interstitial&#xD;
        pneumonias, other chronic fibrosing interstitial pneumonias with a progressive phenotype, and&#xD;
        interstitial pneumonia associated with Scleroderma and related cases of patients carrying a&#xD;
        mutation on one of the telomere-associated genes.&#xD;
  &#xD;
        This is a national, observational, longitudinal, multicenter study that will be conducted&#xD;
        retrospectively and prospectively. It aims to collect consistent and comparable clinical data&#xD;
        for patients and their relatives, whether they carry a mutation or not, affected by diffuse&#xD;
        idiopathic interstitial pneumopathy.&#xD;
  &#xD;
        The expected duration of the study, including data analysis, is approximately 10 years (5&#xD;
        years for participant enrollment and 5 years of follow-up, in addition to the steps for data&#xD;
        management and statistical analyses).&#xD;
  &#xD;
        Each participating center will inform every participant by providing an information sheet,&#xD;
        and their written consent will be obtained before including them in the study and commencing&#xD;
        data collection.&#xD;
  &#xD;
        Prospective medical data will be collected at 6 months to 1 year after enrollment and then at&#xD;
        least once per year for patients up to 5 years and 5 years for their relatives.&#xD;
  &#xD;
        Participants will complete a self-questionnaire during their regular follow-up consultations&#xD;
        or by accessing a secure interface.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 19, 2022</start_date>
    <completion_date type="Anticipated">March 19, 2031</completion_date>
    <primary_completion_date type="Anticipated">March 19, 2031</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>Family history</measure>
      <time_frame>At inclusion visit</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical parameters : respiratory examination</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Collection of biological parameters</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Chest scan</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Chest radiographs</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Pulmonary scintigraphy</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Chest RMI</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Echocardiography</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Search for infectious agents</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Bronchoscopy</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Lung function tests: Arterial blood gas</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Lung function tests: if available sleep gas exchange</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Lung function tests: polysomnography</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Lung tissue examination, if available Lung biopsy (surgical, transbronchial), Lung explant, if lung transplant</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of digestive function</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of cardiac function (cardiovascular ultrasound)</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of cardiac function (cardiac magnetic resonance imaging)</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of cardiac function ( right heart catheterization)</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Dermatological evaluation</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Fertility evaluation</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Bone densitometry</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Collection of patient treatments</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients</time_frame>
      <description>treatment name, dosage, start and end dates..</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Genetic assessment</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
      <description>Identification of gene factors involved in disease initiation and progression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The description of data on environmental and co-morbidity factors impacting disease severity</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Validate already published biomarkers candidates for disease diagnosis</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Validate already published biomarkers candidates for disease progression.</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SARS-CoV2: Method of diagnosis, symptoms, medical supports, treatments</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immuno-hematological assessment</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
      <description>Presence of macrocytosis, thrombocytopenia, anaemia, dysmyelopoiesis, myelodysplasia, aplasia, or acute leukaemia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic assessment (hepatocellular carcinoma)</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
      <description>Liver function tests, cirrhosis, hepatocellular carcinoma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic assessment (Liver function tests)</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic assessment (cirrhosis)</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cutaneous assessment</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary emphysema on the thoracic scanner and evaluated by double reading of the scanner</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spermogram assessment</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hormonal evaluation</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Osteopenia, osteoporosis</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Solid cancer including skin cancer and cervical dysplasia (current cancer and history of cancer)</measure>
      <time_frame>Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">3000</enrollment>
    <condition>Interstitial Lung Diseases</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study cohort will include:&#xD;
  &#xD;
            -  Prevalent and incident cases of symptomatic adult and paediatric patients with a&#xD;
               diagnosed IIP, other chronic fibrosing ILDs with progressive phenotype, SSc-associated&#xD;
               ILDs. In total, 2850 patients are expected. 1600 patients are already included via the&#xD;
               initial protocol RaDiCo-PID.&#xD;
  &#xD;
            -  Cases corresponding to patients included as 1st degree relatives of a symptomatic&#xD;
               diagnosed FPF patient carrying a specific mutation. About 150 relatives are expected&#xD;
               in this protocol. No inclusion in initial protocol because it is a new population.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Confirmed diagnosis of IIP established based on clinical, radiological, or functional&#xD;
          criteria.&#xD;
  &#xD;
          Confirmed diagnosis of non-IPF progressive fibrotic interstitial lung disease (PF-ILD) with&#xD;
          fibrosis ≥ 10% on CT scan, disease worsening not related to pulmonary embolism,&#xD;
          decompensated heart failure, or lower respiratory tract infection, and disease progression&#xD;
          despite &quot;appropriate management&quot; evaluated over a period of up to 24 months:&#xD;
  &#xD;
            -  A relative decline in Forced Vital Capacity (FVC) of at least 10% from predicted&#xD;
               value, with or without clinical deterioration, or&#xD;
  &#xD;
            -  A combination of at least 2 of the following criteria: a relative decline in FVC&#xD;
               between 5% and 10% from predicted value, worsening respiratory symptoms, increased&#xD;
               extent of pulmonary fibrosis on thoracic CT scan.&#xD;
  &#xD;
          Confirmed diagnosis of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)&#xD;
          (American College of Rheumatology criteria), with a total score ≥ 9 and disease extent&#xD;
          involving ≥ 10% of the lungs (defined by reticular abnormalities, honeycombing, and&#xD;
          ground-glass opacities) on high-resolution CT (HRCT) scan.&#xD;
  &#xD;
          For relatives: First degree relatives of patients carrying a mutation in TERT, TERC, RTEL1,&#xD;
          TINF2, DKC1, PARN genes, and other telomere related genes that may be described in the&#xD;
          future and included.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Vincent Cottin, Pr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre National de Référence des maladies pulmonaires rares</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vincent Cottin, Pr</last_name>
      <phone>(33) 4 27 85 77 00</phone>
      <email>vincent.cottin@chu-lyon.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Annick Clement, Pr</last_name>
      <email>annick.clement@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>RaDiCo-ILD2</name>
        <address>
          <city>Paris</city>
          <state>Île-de-France</state>
          <zip>75012</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sonia Gueguen, PHD</last_name>
        <phone>0033 6 88 34 54 08</phone>
        <email>sonia.gueguen@radico.fr</email>
      </contact>
      <investigator>
        <last_name>Vincent Cottin, Pr</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pediatric Interstitial Lung Diseases</keyword>
    <keyword>Idiopathic Pulmonary Fibrosis</keyword>
    <keyword>Pediatrics / adult</keyword>
    <keyword>Idiopathic Interstitial Pneumonia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06036719
  org study id: C20-58
  secondary id: 2021-A00094-37
  nct id: NCT06036719
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The concerned patients are children and adults suffering from idiopathic interstitial
        pneumonias, other chronic fibrosing interstitial pneumonias with a progressive phenotype, and
        interstitial pneumonia associated with Scleroderma and related cases of patients carrying a
        mutation on one of the telomere-associated genes.
  
        This is a national, observational, longitudinal, multicenter study that will be conducted
        retrospectively and prospectively. It aims to collect consistent and comparable clinical data
        for patients and their relatives, whether they carry a mutation or not, affected by diffuse
        idiopathic interstitial pneumopathy.
  
        The expected duration of the study, including data analysis, is approximately 10 years (5
        years for participant enrollment and 5 years of follow-up, in addition to the steps for data
        management and statistical analyses).
  
        Each participating center will inform every participant by providing an information sheet,
        and their written consent will be obtained before including them in the study and commencing
        data collection.
  
        Prospective medical data will be collected at 6 months to 1 year after enrollment and then at
        least once per year for patients up to 5 years and 5 years for their relatives.
  
        Participants will complete a self-questionnaire during their regular follow-up consultations
        or by accessing a secure interface.
  observational model: Cohort
  time perspective: Prospective
  measure: Family history
  time frame: At inclusion visit
  measure: Clinical parameters : respiratory examination
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Collection of biological parameters
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Chest scan
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Chest radiographs
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Pulmonary scintigraphy
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Chest RMI
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Echocardiography
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Search for infectious agents
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Bronchoscopy
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Lung function tests: Arterial blood gas
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Lung function tests: if available sleep gas exchange
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Lung function tests: polysomnography
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Lung tissue examination, if available Lung biopsy (surgical, transbronchial), Lung explant, if lung transplant
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Assessment of digestive function
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Assessment of cardiac function (cardiovascular ultrasound)
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Assessment of cardiac function (cardiac magnetic resonance imaging)
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Assessment of cardiac function ( right heart catheterization)
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Dermatological evaluation
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Fertility evaluation
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Bone densitometry
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Collection of patient treatments
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients
  description: treatment name, dosage, start and end dates..
  measure: Genetic assessment
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  description: Identification of gene factors involved in disease initiation and progression
  measure: The description of data on environmental and co-morbidity factors impacting disease severity
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Validate already published biomarkers candidates for disease diagnosis
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Validate already published biomarkers candidates for disease progression.
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: SARS-CoV2: Method of diagnosis, symptoms, medical supports, treatments
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Immuno-hematological assessment
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  description: Presence of macrocytosis, thrombocytopenia, anaemia, dysmyelopoiesis, myelodysplasia, aplasia, or acute leukaemia
  measure: Hepatic assessment (hepatocellular carcinoma)
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  description: Liver function tests, cirrhosis, hepatocellular carcinoma
  measure: Hepatic assessment (Liver function tests)
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Hepatic assessment (cirrhosis)
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Cutaneous assessment
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Pulmonary emphysema on the thoracic scanner and evaluated by double reading of the scanner
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Spermogram assessment
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Hormonal evaluation
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Osteopenia, osteoporosis
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  measure: Solid cancer including skin cancer and cervical dysplasia (current cancer and history of cancer)
  time frame: Through study completion, at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year for patients, and at inclusion and 5 years for relatives
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Vincent Cottin, Pr
  role: Principal Investigator
  affiliation: Centre National de Référence des maladies pulmonaires rares
  last name: Vincent Cottin, Pr
  phone: (33) 4 27 85 77 00
  email: vincent.cottin@chu-lyon.fr
  last name: Annick Clement, Pr
  email: annick.clement@aphp.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  sharing ipd: Undecided