<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/NCT03769987</url>
  </required_header>
  <id_info>
    <org_study_id>REAS</org_study_id>
    <nct_id>NCT03769987</nct_id>
  </id_info>
  <brief_title>Registry for Advanced Sarcodiosis</brief_title>
  <acronym>REAS</acronym>
  <official_title>Registry for Advanced Sarcoidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cincinnati</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>
      Registry with evaluation and genetic information of patients with advanced sarcoidosis and&#xD;
      matched sarcoidosis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>2 years</time_frame>
    <description>Determine how many people die during follow up</description>
  </primary_outcome>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Sarcoidosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation</intervention_name>
    <description>observe patients every 6 months</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Advanced sarcoidosis is defined by the presence of one or more of the following features:&#xD;
&#xD;
          1. Advanced pulmonary disease as defined by one or more of the following&#xD;
&#xD;
          2. Symptomatic cardiac disease due to sarcoidosis by either MRI or PET scanning and&#xD;
&#xD;
          3. Symptomatic neurologic disease&#xD;
&#xD;
          4. Patients who have received third line therapy (anti-TNF antibodies, rituximab, or RCI)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Life expectancy of at least 2 years.&#xD;
&#xD;
          -  Pulmonary function tests (spirometry) within one month of entry or willing to under&#xD;
             pulmonary function testing on the day of study enrollment&#xD;
&#xD;
          -  Sarcoidosis as characterized as either advanced or non-advanced (see protocol for&#xD;
             definition of advanced disease)&#xD;
&#xD;
          -  Subjects must be able to understand and be willing to sign the written informed&#xD;
             consent form. A signed informed consent form must be appropriately obtained prior to&#xD;
             the conduct of any trial-specific procedure.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Subjects with a medical disorder, condition, or history of such that would impair the&#xD;
             subject's ability to participate or complete this study in the opinion of the&#xD;
             investigator&#xD;
&#xD;
          -  Inability to comply with the protocol and/or not willing or not available for&#xD;
             follow-up assessments.&#xD;
&#xD;
          -  Any condition which, in the investigator's opinion, makes the subject unsuitable for&#xD;
             trial participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Baughman</last_name>
    <role>Study Chair</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert Baughman</last_name>
    <phone>513-584-5225</phone>
    <email>bob.baughman@uc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert P Baughman, MD</last_name>
      <phone>513-584-5225</phone>
      <email>bob.baughman@uc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Elyse E Lower</last_name>
      <phone>513-584-3829</phone>
      <email>ELower@ucmail.uc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>February 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Robert P Baughman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis</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/NCT03769987
org study id: REAS
nct id: NCT03769987
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Registry with evaluation and genetic information of patients with advanced sarcoidosis and
      matched sarcoidosis
observational model: Case-Control
time perspective: Prospective
measure: Death
time frame: 2 years
description: Determine how many people die during follow up
intervention type: Other
intervention name: observation
description: observe patients every 6 months
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 100 Years
healthy volunteers: No
last name: Robert Baughman
role: Study Chair
affiliation: University of Cincinnati
last name: Robert Baughman
phone: 513-584-5225
email: bob.baughman@uc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Robert P Baughman
investigator title: Professor
mesh term: Sarcoidosis
sharing ipd: No