<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/NCT02988388</url>
  </required_header>
  <id_info>
    <org_study_id>LTR01</org_study_id>
    <nct_id>NCT02988388</nct_id>
  </id_info>
  <brief_title>Lung Tissue Research Consortium</brief_title>
  <acronym>LTRC</acronym>
  <official_title>Lung Tissue Research Consortium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Heart, Lung, and Blood Institute (NHLBI)</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>
      The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung&#xD;
      tissues from donors and preparing and distributing collections of tissue specimens to&#xD;
      researchers within and outside the LTRC. Collections of specimens will be linked to&#xD;
      individual clinical data appropriate to the particular disease. The primary goal of the LTRC&#xD;
      is to identify participants with suspected lung cancer or metastatic disease who are willing&#xD;
      to provide informed consent for research use of their specimens and data. Secondarily, the&#xD;
      LTRC investigators intend to collect clinical data, limited exposure data, physiologic&#xD;
      studies, and radiographic studies from these participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2017</start_date>
  <completion_date type="Actual">February 21, 2019</completion_date>
  <primary_completion_date type="Actual">January 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical diagnosis</measure>
    <time_frame>Two months following surgery</time_frame>
    <description>A final diagnosis of the participant's lung disease will be rendered by the clinical center PI.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">247</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>Lung biopsy/lobectomy</arm_group_label>
    <description>Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung biopsy/lobectomy</intervention_name>
    <description>Lung biopsies and lobectomies are not experimental. Participants will undergo a lung biopsy or a lobectomy as part of standard of care.</description>
    <arm_group_label>Lung biopsy/lobectomy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      For a subset of LTRC participants who provide applicable consent, a portion of collected&#xD;
      blood will be stored in a Paxgene DNA tube for DNA generation. DNA will be stored in a&#xD;
      central laboratory and available for request by qualified researchers.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or&#xD;
        metastases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or&#xD;
             metastases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cystic fibrosis or pulmonary hypertension.&#xD;
&#xD;
          -  Any other condition that, in the judgment of the investigator, precludes&#xD;
             participation.&#xD;
&#xD;
          -  Failure to obtain written consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tom Croxton</last_name>
    <role>Study Director</role>
    <affiliation>National Heart, Lung, and Blood Institute (NHLBI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>14213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>March 7, 2019</last_update_submitted>
  <last_update_submitted_qc>March 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2019</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>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may submit an application for access to LTRC participant data including clinical and pathological diagnoses, radiological images (CT scans) and diagnoses, environmental and occupational exposure questionnaires, respiratory questionnaires and assessments, pulmonary function testing, concomitant therapy, medical history, smoking history, and laboratory measures. Gene array data are also available for a subset of participants. All data are de-identified. No protected health information is released to researchers external to LTRC.</ipd_description>
  </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/NCT02988388
org study id: LTR01
nct id: NCT02988388
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung
      tissues from donors and preparing and distributing collections of tissue specimens to
      researchers within and outside the LTRC. Collections of specimens will be linked to
      individual clinical data appropriate to the particular disease. The primary goal of the LTRC
      is to identify participants with suspected lung cancer or metastatic disease who are willing
      to provide informed consent for research use of their specimens and data. Secondarily, the
      LTRC investigators intend to collect clinical data, limited exposure data, physiologic
      studies, and radiographic studies from these participants.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Clinical diagnosis
time frame: Two months following surgery
description: A final diagnosis of the participant's lung disease will be rendered by the clinical center PI.
arm group label: Lung biopsy/lobectomy
description: Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.
intervention type: Procedure
intervention name: Lung biopsy/lobectomy
description: Lung biopsies and lobectomies are not experimental. Participants will undergo a lung biopsy or a lobectomy as part of standard of care.
arm group label: Lung biopsy/lobectomy
For a subset of LTRC participants who provide applicable consent, a portion of collected
      blood will be stored in a Paxgene DNA tube for DNA generation. DNA will be stored in a
      central laboratory and available for request by qualified researchers.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tom Croxton
role: Study Director
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Lung Diseases, Interstitial
sharing ipd: Yes
ipd description: Qualified researchers may submit an application for access to LTRC participant data including clinical and pathological diagnoses, radiological images (CT scans) and diagnoses, environmental and occupational exposure questionnaires, respiratory questionnaires and assessments, pulmonary function testing, concomitant therapy, medical history, smoking history, and laboratory measures. Gene array data are also available for a subset of participants. All data are de-identified. No protected health information is released to researchers external to LTRC.