<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/NCT04442711</url>
  </required_header>
  <id_info>
    <org_study_id>PFBIO-EXA</org_study_id>
    <nct_id>NCT04442711</nct_id>
  </id_info>
  <brief_title>Cohort of IPF Patients Experiencing an Exacerbation</brief_title>
  <official_title>Pulmonary Fibrosis Biomarkers During Exacerbation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Extension of the PFBIO cohort which includes patients with newly diagnosed idiopathic&#xD;
      pulmonary fibrosis (IPF) for longitudinal follow-up for up to 5 years.&#xD;
&#xD;
      In the PFBIO-EXA extension, patients are included if they experience an exacerbation, or&#xD;
      other increase in respiratory symptoms requiring hospital admission, for further collection&#xD;
      of clinical and biological data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate the diagnostic and prognostic value of clinical and&#xD;
      blood biomarkers during exacerbations, or other increase in respiratory symptoms requiring&#xD;
      hospital admission in patients with IPF.&#xD;
&#xD;
      Patients that are already included in the PFBIO-cohort (NCT02755441) and who are admitted to&#xD;
      hospital with an increase in respiratory symptoms, are also included in PFBIO-EXA.&#xD;
&#xD;
      Patients are recruited within 24 hrs. from hospital admission with respiratory worsening,&#xD;
      where clinical data, and blood samples are collected. The blood samples are investigated for&#xD;
      the same blood biomarkers as PFBIO.&#xD;
&#xD;
      Patient related outcomes are also collected, including quality-of-life questionnaires and&#xD;
      outcomes of the exacerbations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 13, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 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>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>All-cause mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days</time_frame>
    <description>All-cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarker levels</measure>
    <time_frame>30 days</time_frame>
    <description>Blood biomarker level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LTOT</measure>
    <time_frame>30 days</time_frame>
    <description>Change in oxygen need</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL</measure>
    <time_frame>30 days</time_frame>
    <description>Score of patient reported quality of life assessed by questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory support</measure>
    <time_frame>30 days</time_frame>
    <description>Need for non-invasive or invasive respiratory support, including oxygen, CPAP, NIV and intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decline in functional level</measure>
    <time_frame>30 days</time_frame>
    <description>Decrease in functional level, e.g. moved to nursing home, hospice or other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment during hospitalization</measure>
    <time_frame>30 days</time_frame>
    <description>Treatment administered for respiratory worsening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment after hospitalization</measure>
    <time_frame>90 days</time_frame>
    <description>Treatment administered after discharge</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>PFBIO-EXA</arm_group_label>
    <description>All patients recruited for PFBIO-EXA from the original PFBIO cohort are included into the cohort.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood serum and plasma are collected within 24 hrs of hospital admission for measurement of&#xD;
      biomarkers.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients already included in PFBIO that are admitted with a respiratory worsening are&#xD;
        eligible for inclusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted with an increase in respiratory symptoms&#xD;
&#xD;
          -  Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide 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>Herlev and Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <state>Copenhagen</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nils Hoyer, MD PhD</last_name>
      <phone>+45 38674200</phone>
      <email>nils.hoyer@regionh.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Nils Hoyer</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Exacerbation</keyword>
  <keyword>Hospitalization</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Outcome</keyword>
  <keyword>Prognosis</keyword>
  <keyword>Diagnosis</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>
  <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/NCT04442711
org study id: PFBIO-EXA
nct id: NCT04442711
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Extension of the PFBIO cohort which includes patients with newly diagnosed idiopathic
      pulmonary fibrosis (IPF) for longitudinal follow-up for up to 5 years.

      In the PFBIO-EXA extension, patients are included if they experience an exacerbation, or
      other increase in respiratory symptoms requiring hospital admission, for further collection
      of clinical and biological data.
The aim of this study is to investigate the diagnostic and prognostic value of clinical and
      blood biomarkers during exacerbations, or other increase in respiratory symptoms requiring
      hospital admission in patients with IPF.

      Patients that are already included in the PFBIO-cohort (NCT02755441) and who are admitted to
      hospital with an increase in respiratory symptoms, are also included in PFBIO-EXA.

      Patients are recruited within 24 hrs. from hospital admission with respiratory worsening,
      where clinical data, and blood samples are collected. The blood samples are investigated for
      the same blood biomarkers as PFBIO.

      Patient related outcomes are also collected, including quality-of-life questionnaires and
      outcomes of the exacerbations.
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: 30 days
description: All-cause mortality
measure: Mortality
time frame: 90 days
description: All-cause mortality
measure: Biomarker levels
time frame: 30 days
description: Blood biomarker level
measure: LTOT
time frame: 30 days
description: Change in oxygen need
measure: QoL
time frame: 30 days
description: Score of patient reported quality of life assessed by questionnaires
measure: Respiratory support
time frame: 30 days
description: Need for non-invasive or invasive respiratory support, including oxygen, CPAP, NIV and intubation
measure: Decline in functional level
time frame: 30 days
description: Decrease in functional level, e.g. moved to nursing home, hospice or other
measure: Treatment during hospitalization
time frame: 30 days
description: Treatment administered for respiratory worsening
measure: Treatment after hospitalization
time frame: 90 days
description: Treatment administered after discharge
arm group label: PFBIO-EXA
description: All patients recruited for PFBIO-EXA from the original PFBIO cohort are included into the cohort.
Blood serum and plasma are collected within 24 hrs of hospital admission for measurement of
      biomarkers.
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: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Nils Hoyer
investigator title: Principal Investigator
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
sharing ipd: No