<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/NCT03035097</url>
  </required_header>
  <id_info>
    <org_study_id>HS-2689</org_study_id>
    <nct_id>NCT03035097</nct_id>
  </id_info>
  <brief_title>Deployment-Related Lung Disease Research Database and Biorepository</brief_title>
  <official_title>Deployment-Related Lung Disease Research Database and Biorepository</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Jewish Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Jewish Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to establish a research database and biorepository for&#xD;
      patients at National Jewish Health (NJH) who served in Operation Iraqi Freedom (OIF) or&#xD;
      Operation Enduring Freedom (OEF). This study will also include civilian contractors who&#xD;
      worked as part of these military operations in Iraq or Afghanistan. The biorepository would&#xD;
      store blood samples obtained from these patients during a clinic visit. The research database&#xD;
      would store prospectively and retrospectively collected clinical and exposure data that would&#xD;
      enable us to comprehensively characterize each case.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If informed consent is obtained, test results and other information collected for clinical&#xD;
      reasons will be entered in a research database designed and maintained by DEOHS staff. The&#xD;
      clinical data collected are part of the routine diagnosis and care of these patients. No&#xD;
      additional procedures are required for the purpose of this research database. Collection of&#xD;
      symptom and exposure data using a questionnaire designed for this study.&#xD;
&#xD;
      All NJH patients who served in southwest Asia will be approached for inclusion in the study.&#xD;
      This will also attempt to contact patients evaluated previously at NJH for deployment-related&#xD;
      lung disease to obtain informed consent to include data from their medical record and the&#xD;
      research questionnaire in the database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>collect symptom and exposure data</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>each subject will complete a questionnaire</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Bronchiolitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biorepository</intervention_name>
    <description>One-time blood draw for blood to be stored in a biorepositoy</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      If patients consent to having blood and tissue collected for the biorepository, the samples&#xD;
      will be collected during a clinic visit. Two DNA PAXgene tubes will be used to collect 17ml&#xD;
      of blood and two RNA PAXgene tubes would be used to collect 5 ml of blood. In addition,&#xD;
      excess bronchoalveolar lavage (BAL) fluid from a clinically-indicated bronchoscopy would also&#xD;
      be collected. Blood and BAL fluid will be frozen and stored in -80 degree C freezers in the&#xD;
      Occupational Medicine Laboratory until processed. If a patient will have a surgical or&#xD;
      transbronchial biopsy as part of his or her clinical evaluation, any excess lung tissue that&#xD;
      has been formalin-fixed and paraffin-embedded will also be collected and stored in the&#xD;
      Occupational Medicine facilities.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who served in the southwest Asia will be approached for inclusion in the study. If&#xD;
        patients agree to participate in the biorepository, a one-time blood draw will occur. If&#xD;
        the subject has had a previous bronchoscopy or a surgical lung biopsy and has excess&#xD;
        samples the study would collect those to add to the biorepository.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Served in the southwest Asia wars&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Did not served in the southwest Asia wars&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lauren Zell-Baran, MPH</last_name>
    <phone>303-398-1187</phone>
    <email>zell-baranl@njhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Zell-Baran, MPH</last_name>
      <phone>303-398-1187</phone>
      <email>zell-baranl@njhealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Zell-Baran LM, Meehan R, Wolff J, Strand M, Krefft SD, Gottschall EB, Macedonia TV, Gross JE, Sanders OL, Pepper GC, Rose CS. Military Occupational Specialty Codes: Utility in Predicting Inhalation Exposures in Post-9/11 Deployers. J Occup Environ Med. 2019 Dec;61(12):1036-1040. doi: 10.1097/JOM.0000000000001731.</citation>
    <PMID>31592941</PMID>
  </reference>
  <reference>
    <citation>Krefft SD, Wolff J, Zell-Baran L, Strand M, Gottschall EB, Meehan R, Rose CS. Respiratory Diseases in Post-9/11 Military Personnel Following Southwest Asia Deployment. J Occup Environ Med. 2020 May;62(5):337-343. doi: 10.1097/JOM.0000000000001817.</citation>
    <PMID>31977922</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Jewish Health</investigator_affiliation>
    <investigator_full_name>Cecile Rose Professor of Medicine</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Lung Diseases</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/NCT03035097
org study id: HS-2689
nct id: NCT03035097
lead sponsor: 
has dmc: No
The purpose of this research study is to establish a research database and biorepository for
      patients at National Jewish Health (NJH) who served in Operation Iraqi Freedom (OIF) or
      Operation Enduring Freedom (OEF). This study will also include civilian contractors who
      worked as part of these military operations in Iraq or Afghanistan. The biorepository would
      store blood samples obtained from these patients during a clinic visit. The research database
      would store prospectively and retrospectively collected clinical and exposure data that would
      enable us to comprehensively characterize each case.
If informed consent is obtained, test results and other information collected for clinical
      reasons will be entered in a research database designed and maintained by DEOHS staff. The
      clinical data collected are part of the routine diagnosis and care of these patients. No
      additional procedures are required for the purpose of this research database. Collection of
      symptom and exposure data using a questionnaire designed for this study.

      All NJH patients who served in southwest Asia will be approached for inclusion in the study.
      This will also attempt to contact patients evaluated previously at NJH for deployment-related
      lung disease to obtain informed consent to include data from their medical record and the
      research questionnaire in the database.
observational model: Other
time perspective: Other
measure: collect symptom and exposure data
time frame: Up to 24 months
description: each subject will complete a questionnaire
intervention type: Other
intervention name: Biorepository
description: One-time blood draw for blood to be stored in a biorepositoy
If patients consent to having blood and tissue collected for the biorepository, the samples
      will be collected during a clinic visit. Two DNA PAXgene tubes will be used to collect 17ml
      of blood and two RNA PAXgene tubes would be used to collect 5 ml of blood. In addition,
      excess bronchoalveolar lavage (BAL) fluid from a clinically-indicated bronchoscopy would also
      be collected. Blood and BAL fluid will be frozen and stored in -80 degree C freezers in the
      Occupational Medicine Laboratory until processed. If a patient will have a surgical or
      transbronchial biopsy as part of his or her clinical evaluation, any excess lung tissue that
      has been formalin-fixed and paraffin-embedded will also be collected and stored in the
      Occupational Medicine facilities.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lauren Zell-Baran, MPH
phone: 303-398-1187
email: zell-baranl@njhealth.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Zell-Baran LM, Meehan R, Wolff J, Strand M, Krefft SD, Gottschall EB, Macedonia TV, Gross JE, Sanders OL, Pepper GC, Rose CS. Military Occupational Specialty Codes: Utility in Predicting Inhalation Exposures in Post-9/11 Deployers. J Occup Environ Med. 2019 Dec;61(12):1036-1040. doi: 10.1097/JOM.0000000000001731.
PMID: 31592941
citation: Krefft SD, Wolff J, Zell-Baran L, Strand M, Gottschall EB, Meehan R, Rose CS. Respiratory Diseases in Post-9/11 Military Personnel Following Southwest Asia Deployment. J Occup Environ Med. 2020 May;62(5):337-343. doi: 10.1097/JOM.0000000000001817.
PMID: 31977922
responsible party type: Principal Investigator
investigator affiliation: National Jewish Health
investigator full name: Cecile Rose Professor of Medicine
investigator title: Principal Investigator
mesh term: Bronchiolitis
mesh term: Lung Diseases
sharing ipd: Undecided