<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/NCT04462068</url>
  </required_header>
  <id_info>
    <org_study_id>SAR3</org_study_id>
    <nct_id>NCT04462068</nct_id>
  </id_info>
  <brief_title>ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients</brief_title>
  <official_title>ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      Sarcoidosis is a multisystem granulomatous disease of unknown cause histologically&#xD;
      characterized by noncaseating granulomas. Genetic factors affect disease course, which is&#xD;
      highly variable and difficult to predict.&#xD;
&#xD;
      This study aims to evaluate the predictive value of ACE and HLA genotypes on disease severity&#xD;
      and progression in Danish patients with sarcoidosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</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>Time to initiation of treatment</measure>
    <time_frame>1 year from diagnosis</time_frame>
    <description>Time to initiation of systemic immunosuppression for sarcoidosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with extrapulmonary organ involvement</measure>
    <time_frame>1 year from diagnosis</time_frame>
    <description>Number of participants diagnosed with extrapulmonary organ involvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1</measure>
    <time_frame>1 year</time_frame>
    <description>Increase/ decline/ no change in FEV1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FVC</measure>
    <time_frame>1 year</time_frame>
    <description>Increase/ decline/ no change in FVC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diffusion capacity</measure>
    <time_frame>1 year</time_frame>
    <description>Increase/ decline/ no change in diffusion capacity</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Sarcoidosis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with sarcoidosis seen in Department of Respiratory Diseases, Aarhus Denmark&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of sarcoidosis&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or unwillingness to adhere to the study&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janne Møller, MD</last_name>
      <phone>0045 78462201</phone>
      <email>jannmoel@rm.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</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>Sarcoidosis</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04462068
org study id: SAR3
nct id: NCT04462068
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sarcoidosis is a multisystem granulomatous disease of unknown cause histologically
      characterized by noncaseating granulomas. Genetic factors affect disease course, which is
      highly variable and difficult to predict.

      This study aims to evaluate the predictive value of ACE and HLA genotypes on disease severity
      and progression in Danish patients with sarcoidosis.
observational model: Cohort
time perspective: Prospective
measure: Time to initiation of treatment
time frame: 1 year from diagnosis
description: Time to initiation of systemic immunosuppression for sarcoidosis
measure: Number of participants with extrapulmonary organ involvement
time frame: 1 year from diagnosis
description: Number of participants diagnosed with extrapulmonary organ involvement
measure: Change in FEV1
time frame: 1 year
description: Increase/ decline/ no change in FEV1
measure: Change in FVC
time frame: 1 year
description: Increase/ decline/ no change in FVC
measure: Change in diffusion capacity
time frame: 1 year
description: Increase/ decline/ no change in diffusion capacity
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Sponsor
mesh term: Sarcoidosis
mesh term: Disease Progression
sharing ipd: Undecided