<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/NCT02187393</url>
  </required_header>
  <id_info>
    <org_study_id>13-3027</org_study_id>
    <secondary_id>R01HL097163</secondary_id>
    <nct_id>NCT02187393</nct_id>
  </id_info>
  <brief_title>Determining in Vitro Properties of Epithelial Cells From Individuals With Genetic Variants Associated With Idiopathic Pulmonary Fibrosis</brief_title>
  <official_title>Determining in Vitro Properties of Epithelial Cells From Individuals With Genetic Variants Associated With Idiopathic Pulmonary Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are trying to understand the role of specific genes in the function of&#xD;
      airway surface cells. The investigators know that there are some common genetic markers that&#xD;
      are associated with various lung diseases. However, most people with these genetic markers&#xD;
      never develop any evidence of lung disease, so it is not understand how or if these markers&#xD;
      play a role in disease. Investigators are asking healthy people to provide three (3) tubes of&#xD;
      blood as well as a sample of cells from their nose. Investigators will use the blood sample&#xD;
      to provide genetic information (specifically, presence or absence of alleles known to be&#xD;
      associated with pulmonary fibrosis). Nose cells from individuals with the genetic markers&#xD;
      that investigators are studying will be grown in the the lab to allow investigators to learn&#xD;
      more about how the cells respond to various forms of environmental stress, such as exposure&#xD;
      to cigarette smoke. The goal of this study is to understand how specific genes affect airway&#xD;
      cell function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Technical difficulties with the wet bench side of proposed studies.&#xD;
  </why_stopped>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>in vitro epithelial integrity measured by transepithelial electrical resistance (TEER), reported in ohms</measure>
    <time_frame>6 weeks</time_frame>
    <description>The in vitro epithelial cell culture process will take approximately 4-6 weeks after the cells collected are thawed. (At the time of collection from study subjects, cells will be frozen until the time of thawing and culturing.) The in vitro epithelial process will take 6 weeks to differentiate epithelial monolayers at which time the tests of epithelial integrity can be performed. Study subjects themselves are not being followed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>gene expression (DSP, MUC5B, genes associated with ER Stress), reported as &quot;fold-change&quot; or &quot;CT mean&quot;</measure>
    <time_frame>6 weeks</time_frame>
    <description>Gene expression assays (designed by Taqman/Life Technologies) will be used to examine expression of genes that we believe are associated with pulmonary fibrosis -- specifically, various mucins (MUC5B, MUC5AC, DSP, and numerous genes associated with endoplasmic reticulum (ER) stress). This will be measured on epithelial monolayers derived in vitro from cells collected from study subjects. The differentiation of epithelial monolayers can take 3-6 weeks depending on the vagaries of the cell culture technique.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Epithelial monolayer permeability (protein and cell permeability)</measure>
    <time_frame>6 weeks.</time_frame>
    <description>Epithelial monolayer permeability as measured by dextran/protein and neutrophil traffic through monolayer in vitro. This will be measured on epithelial monolayers derived in vitro from cells collected from study subjects. The differentiation of epithelial monolayers can take 3-6 weeks depending on the vagaries of the cell culture technique.</description>
  </other_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <condition>Healthy</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  (3) tubes of blood&#xD;
&#xD;
        -  sample of cells from the nose&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        normal healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age greater than 18 years of age&#xD;
&#xD;
          2. Ability to provide informed consent&#xD;
&#xD;
          3. Patent bilateral nares&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant nasal or sinus disease precluding nasal brushing&#xD;
&#xD;
          2. A history of or ongoing epistaxis (nose-bleeding)&#xD;
&#xD;
          3. Acute upper respiratory illness&#xD;
&#xD;
          4. Ongoing treatment of respiratory or sinus illness with antibiotics&#xD;
&#xD;
          5. Pregnancy&#xD;
&#xD;
          6. Age less than 18 years&#xD;
&#xD;
          7. Infection with human immunodeficiency virus (HIV) or viral hepatitides (Hepatitis B,&#xD;
             Hepatitis C)&#xD;
&#xD;
          8. Prior volunteer for the same study&#xD;
&#xD;
          9. Known diagnosis of cystic fibrosis or other ciliary disorder (example: primary ciliar&#xD;
             dyskinesia)&#xD;
&#xD;
         10. Treatment with anticoagulants (examples: warfarin/coumadin, low molecular weight&#xD;
             heparins, direct thrombin inhibitors such as dabigatran, anti-platelet agents such as&#xD;
             P2Y12 inhibitors like clopidogrel and prasugrel, aspirin, ticagrelor, or factor Xa&#xD;
             inhibitors such as rivaroxaban)&#xD;
&#xD;
         11. Known thrombocytopenia (example: immune thrombocytopenic purpura)&#xD;
&#xD;
         12. Ongoing chemotherapy&#xD;
&#xD;
         13. Known platelet dysfunction or bleeding diathesis/hemophilia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Schwartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>March 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>November 25, 2015</last_update_submitted>
  <last_update_submitted_qc>November 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epithelial cell function of cells from individuals with various genotypes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02187393
org study id: 13-3027
secondary id: R01HL097163
nct id: NCT02187393
lead sponsor: 
collaborator: 
has dmc: No
The investigators are trying to understand the role of specific genes in the function of
      airway surface cells. The investigators know that there are some common genetic markers that
      are associated with various lung diseases. However, most people with these genetic markers
      never develop any evidence of lung disease, so it is not understand how or if these markers
      play a role in disease. Investigators are asking healthy people to provide three (3) tubes of
      blood as well as a sample of cells from their nose. Investigators will use the blood sample
      to provide genetic information (specifically, presence or absence of alleles known to be
      associated with pulmonary fibrosis). Nose cells from individuals with the genetic markers
      that investigators are studying will be grown in the the lab to allow investigators to learn
      more about how the cells respond to various forms of environmental stress, such as exposure
      to cigarette smoke. The goal of this study is to understand how specific genes affect airway
      cell function.
time perspective: Prospective
measure: in vitro epithelial integrity measured by transepithelial electrical resistance (TEER), reported in ohms
time frame: 6 weeks
description: The in vitro epithelial cell culture process will take approximately 4-6 weeks after the cells collected are thawed. (At the time of collection from study subjects, cells will be frozen until the time of thawing and culturing.) The in vitro epithelial process will take 6 weeks to differentiate epithelial monolayers at which time the tests of epithelial integrity can be performed. Study subjects themselves are not being followed.
measure: gene expression (DSP, MUC5B, genes associated with ER Stress), reported as "fold-change" or "CT mean"
time frame: 6 weeks
description: Gene expression assays (designed by Taqman/Life Technologies) will be used to examine expression of genes that we believe are associated with pulmonary fibrosis -- specifically, various mucins (MUC5B, MUC5AC, DSP, and numerous genes associated with endoplasmic reticulum (ER) stress). This will be measured on epithelial monolayers derived in vitro from cells collected from study subjects. The differentiation of epithelial monolayers can take 3-6 weeks depending on the vagaries of the cell culture technique.
measure: Epithelial monolayer permeability (protein and cell permeability)
time frame: 6 weeks.
description: Epithelial monolayer permeability as measured by dextran/protein and neutrophil traffic through monolayer in vitro. This will be measured on epithelial monolayers derived in vitro from cells collected from study subjects. The differentiation of epithelial monolayers can take 3-6 weeks depending on the vagaries of the cell culture technique.
-  (3) tubes of blood

        -  sample of cells from the nose
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David A Schwartz, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis