<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/NCT03271333</url>
  </required_header>
  <id_info>
    <org_study_id>2015_49</org_study_id>
    <secondary_id>2016-A00722-49</secondary_id>
    <nct_id>NCT03271333</nct_id>
  </id_info>
  <brief_title>Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma.</brief_title>
  <acronym>SCLERO-PID</acronym>
  <official_title>Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.</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>
      Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one&#xD;
      of the leading cause of death in this condition. The main objective of this study is to&#xD;
      prospectively describe the evolution of DIP overtime and to find prognosis factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 10, 2018</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">April 2025</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>composite criteria: forced vital capacity and CO diffusing capacity</measure>
    <time_frame>At 24 months</time_frame>
    <description>Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 24 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>composite criteria: forced vital capacity and CO diffusing capacity</measure>
    <time_frame>At 12 months</time_frame>
    <description>Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 12 months.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Systemic Sclerosis</condition>
  <arm_group>
    <arm_group_label>patients with systemic sclerosis</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>lung function tests</intervention_name>
    <description>Patients hospitalized realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes)</description>
    <arm_group_label>patients with systemic sclerosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with systemic sclerosis and Diffuse Infiltrating Pneumonia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  systemic sclerosis&#xD;
&#xD;
          -  Diffuse Infiltrating Pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  other lung diseases&#xD;
&#xD;
          -  non French native&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Launay, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Launay, MD,PhD</last_name>
    <phone>3 20 44 42 95</phone>
    <phone_ext>+33</phone_ext>
    <email>david.launay@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Claude Huriez, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Launay, MD,PHD</last_name>
      <email>david.launay@chru-lille.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AH-HP, Hôpital Saint Antoine</name>
      <address>
        <city>Paris 12</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0149282000</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 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>Pneumonia</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</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/NCT03271333
org study id: 2015_49
secondary id: 2016-A00722-49
nct id: NCT03271333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one
      of the leading cause of death in this condition. The main objective of this study is to
      prospectively describe the evolution of DIP overtime and to find prognosis factors.
observational model: Cohort
time perspective: Prospective
measure: composite criteria: forced vital capacity and CO diffusing capacity
time frame: At 24 months
description: Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 24 months.
measure: composite criteria: forced vital capacity and CO diffusing capacity
time frame: At 12 months
description: Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 12 months.
arm group label: patients with systemic sclerosis
intervention type: Other
intervention name: lung function tests
description: Patients hospitalized realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes)
arm group label: patients with systemic sclerosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: David Launay, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: David Launay, MD,PhD
phone: 3 20 44 42 95
phone ext: +33
email: david.launay@chru-lille.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
sharing ipd: No