<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/NCT01718990</url>
  </required_header>
  <id_info>
    <org_study_id>PPG-IPF</org_study_id>
    <nct_id>NCT01718990</nct_id>
  </id_info>
  <brief_title>Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis</brief_title>
  <official_title>Prospective, Longitudinal Cohort Trial of Patients With Idiopathic Pulmonary Fibrosis (IPF) and Healthy Control Patients. Clinical Data, Blood, and Bronchiolavage (BAL) Fluid Will be Collected Over 12 Months.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Drug discovery can take many years especially since most studies to measure effectiveness&#xD;
      depend on clinical outcomes like pulmonary function tests and hospitalizations.&#xD;
&#xD;
      This is an observational study designed to collect information, blood, and bronchoalveolar&#xD;
      lavage fluid in people who have IPF and those who do not. The people who have IPF will be&#xD;
      followed for 12 months to collect more biological samples and record clinically relevant&#xD;
      information.&#xD;
&#xD;
      The goal of this study is to identify new molecular markers that are measurable and reliable&#xD;
      in people who have IPF. It is hoped that these markers can be used in future drug studies to&#xD;
      significantly speed up the process of finding drugs that help.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Molecular Markers</measure>
    <time_frame>12 months</time_frame>
    <description>We anticipate that we will successfully enroll 60 subjects with IPF in a 12 month longitudinal cohort study and provide biological samples (Bronchiolavage (BAL), alveolar macrophages, and blood) to Projects 1-3 for use in identifying mechanistically-informative markers of alveolar epithelial cell ER stress, αvβ6-mediated TGFβ activation, and EMT. We expect that levels of some of these mechanistic markers will be measurable in patient samples, and may be differentially present in IPF compared to normal controls. Variations in baseline levels of mechanistically-informative molecular markers may identify subgroups of Idiopathic Pulmonary Fibrosis (IPF) patients that share distinct clinical phenotypes.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis (IPF)</condition>
  <arm_group>
    <arm_group_label>Patients with Idiopathic Pulmonary Fibrosis (IPF)</arm_group_label>
    <description>Sixty patients with IPF will be included in this prospective cohort;15 IPF patients per year for years 1-4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Sixty normal controls will be recruited from volunteers.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma, Bronchiolavage (BAL) supernatant, and BAL cell pellets&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        IPF&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 35 to 80 years&#xD;
&#xD;
          -  a diagnosis of IPF by consensus criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any condition that makes the patient at unacceptable risk for bronchoscopy&#xD;
&#xD;
          -  the presence of significant co-existing emphysema on HRCT&#xD;
&#xD;
          -  active cigarette smoking (defined as smoking within the last 6 months)&#xD;
&#xD;
          -  the presence of a significant co-morbidity felt to limit life expectancy to less than&#xD;
             12 months.&#xD;
&#xD;
          -  active listing for lung transplantation&#xD;
&#xD;
          -  inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harold Collard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</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>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/NCT01718990
org study id: PPG-IPF
nct id: NCT01718990
lead sponsor: 
has dmc: Yes
Drug discovery can take many years especially since most studies to measure effectiveness
      depend on clinical outcomes like pulmonary function tests and hospitalizations.

      This is an observational study designed to collect information, blood, and bronchoalveolar
      lavage fluid in people who have IPF and those who do not. The people who have IPF will be
      followed for 12 months to collect more biological samples and record clinically relevant
      information.

      The goal of this study is to identify new molecular markers that are measurable and reliable
      in people who have IPF. It is hoped that these markers can be used in future drug studies to
      significantly speed up the process of finding drugs that help.
observational model: Cohort
time perspective: Prospective
measure: Molecular Markers
time frame: 12 months
description: We anticipate that we will successfully enroll 60 subjects with IPF in a 12 month longitudinal cohort study and provide biological samples (Bronchiolavage (BAL), alveolar macrophages, and blood) to Projects 1-3 for use in identifying mechanistically-informative markers of alveolar epithelial cell ER stress, αvβ6-mediated TGFβ activation, and EMT. We expect that levels of some of these mechanistic markers will be measurable in patient samples, and may be differentially present in IPF compared to normal controls. Variations in baseline levels of mechanistically-informative molecular markers may identify subgroups of Idiopathic Pulmonary Fibrosis (IPF) patients that share distinct clinical phenotypes.
arm group label: Patients with Idiopathic Pulmonary Fibrosis (IPF)
description: Sixty patients with IPF will be included in this prospective cohort;15 IPF patients per year for years 1-4.
arm group label: Healthy Volunteers
description: Sixty normal controls will be recruited from volunteers.
Serum, plasma, Bronchiolavage (BAL) supernatant, and BAL cell pellets
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harold Collard, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis