<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/NCT04503044</url>
  </required_header>
  <id_info>
    <org_study_id>1628689</org_study_id>
    <nct_id>NCT04503044</nct_id>
  </id_info>
  <brief_title>ILAs in CT Lung Cancer Screening Population</brief_title>
  <official_title>Interstitial Lung Abnormalities--Qualitative Imaging Cohort Study in CT Lung Cancer Screening Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lahey Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Lahey Clinic</source>
  <oversight_info>
    <has_dmc>No</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>
      Interstitial Lung Abnormalities (ILA) have been previously defined as nondependent changes&#xD;
      affecting more than 5% of any lung zone on computed tomography (CT) scans of the lung.&#xD;
      Several studies suggest that the prevalence of ILA in participants in non-pulmonary research&#xD;
      studies ranges anywhere from 7-9%. Work over the last decade has shown that, despite previous&#xD;
      characterization as an asymptomatic research finding, ILA has significant clinical and&#xD;
      biological consequences. These include reduced exercise capacity, functional limitations,&#xD;
      decreased lung volumes, increased mortality, and in some cases histopathology similar to&#xD;
      Idiopathic Pulmonary Fibrosis (IPF). ILA have been detected in lung cancer screening cohorts,&#xD;
      where the prevalence of ILA is estimated to be between (10%-20%) to those noted in other&#xD;
      research cohorts. Given that a significant proportion of those will have progression, CT lung&#xD;
      cancer screening (CTLS) cohorts represent an ideal catchment population for future research&#xD;
      and clinical trials. Lahey Hospital and Medical Center was one of the earliest clinical&#xD;
      centers to develop a CTLS program in the country. Investigators propose to qualitatively&#xD;
      characterize ILA in a large clinical CTLS population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators propose a retrospective, single-center study with following aims:&#xD;
&#xD;
        1. Characterize the prevalence and incidence of ILA at baseline and 5 year follow-up,&#xD;
           respectively, and associated imaging phenotypes in CTLS cohort.&#xD;
&#xD;
        2. Baseline qualitative ILA features associated with clinical outcomes: Lung Cancer,&#xD;
           Hospitalization, and Mortality.&#xD;
&#xD;
        3. Baseline qualitative ILA features associated with progressive ILA and fibrotic lung&#xD;
           disease.&#xD;
&#xD;
        4. Clinical opportunity: to determine the % of CTLS patients with ILA who are at risk for&#xD;
           progressive and development of fibrotic lung disease and who would benefit from&#xD;
           specialized care referral and potential enrollment in clinical trials utilizing proven&#xD;
           antifibrotic therapies&#xD;
&#xD;
      Patient Selection:&#xD;
&#xD;
      All clinical CT Lung Cancer Screening (CTLS) patients at Lahey Hospital and Medical Center&#xD;
      (LHMC), Burlington, MA from January 1st, 2012 through September 30th, 2014 who had an in&#xD;
      network primary care physician (n=1703). Patients with T4 screening scans will be scored for&#xD;
      progression (n=653). To qualify for our study, patients had to satisfy the National&#xD;
      Comprehensive Cancer Network (NCCN) Guidelines® Lung Cancer Screening Version 1.2012&#xD;
      high-risk criteria for lung cancer. Based on the NCCN Guidelines®, individuals eligible for&#xD;
      lung cancer screening can be classified into NCCN group 1 and 2 as previously described.&#xD;
      Patients in both groups were asymptomatic and had a physician order for CTLS, were free of&#xD;
      lung cancer for ≥ 5 years, and had no known metastatic disease.&#xD;
&#xD;
      Clinical Variables:&#xD;
&#xD;
      Clinical variables were collected prospectively as part of the CTLS program and stored in a&#xD;
      centralized data repository. Additional clinical variables not already available in this data&#xD;
      repository will be collected retrospectively by manual review of the electronic medical&#xD;
      record or pulled directly from the EMR and stored utilizing a custom-designed database&#xD;
      (FileMaker ProVersion 11; Filemaker Inc, Santa Clara, California). Data was obtained through&#xD;
      September 30th, 2019, patient demographics, past medical history, PFTs, immunization records,&#xD;
      whether the patient was managed by a pulmonologist, and for hospital admissions with&#xD;
      principal admission diagnoses. Hospital admissions will be collected using Lahey&#xD;
      administrative coding data. Principal admission diagnoses of COPD, PNA, and CHF will be&#xD;
      characterized based on diagnosis codes per 2018 Center for Medicare and Medicaid Services&#xD;
      (CMS) condition-specific measures.&#xD;
&#xD;
      CT Imaging:&#xD;
&#xD;
      Clinically acquired, CTLS examinations which were performed on ≥64-row multidetector CT&#xD;
      scanners (LightSpeed VCT and Discovery VCT [GE Medical Systems, Milwaukee, Wisconsin];&#xD;
      Somatom Definition [Siemens AG, Erlangen, Germany]; iCT [Philips Medical Systems, Andover,&#xD;
      Massachusetts]) at 100 kV and 30 to 100 mA, depending on the scanner and the availability of&#xD;
      iterative reconstruction software. Axial images were obtained at 1.25- to 1.5-mm thickness&#xD;
      with 50% overlap and reconstructed with both soft tissue and lung kernels.&#xD;
&#xD;
      Qualitative ILA Scoring:&#xD;
&#xD;
      CT images will be scored utilizing Philips Intellispace PACS version 4.4 with clinical grade&#xD;
      monitors. Scoring will be performed independently by two thoracic radiologists as described&#xD;
      previously. Scores that are discordant between the two radiologists will be scored by a third&#xD;
      by a pulmonologist with expertise in ILD.&#xD;
&#xD;
      ILA: The presence of ILA features will be scores as (Yes/No/Indeterminate). Indeterminate&#xD;
      will be defined as features identified unilaterally/focal involvement.&#xD;
&#xD;
      ILA features that will be scored include: A) non dependent ground glass, B) reticular&#xD;
      abnormalities, C) traction bronchiectasis and D) honeycombing.&#xD;
&#xD;
      A) Non Dependent ground glass: (Yes/No/Indeterminate) defined as hazy increased attenuation&#xD;
      of the lung with preservation of bronchial and vascular margins.&#xD;
&#xD;
      B) Reticular abnormalities: (Yes/No/Indeterminate) defined as a collection of innumerable&#xD;
      small linear opacities that, by summation, produce an appearance resembling a net.&#xD;
&#xD;
      C) Traction Bronchiectasis: (Yes/No/Indeterminate) defined Traction bronchiectasis and&#xD;
      traction bronchiolectasis respectively represents irregular bronchial and bronchiolar&#xD;
      dilatation caused by surrounding retractile pulmonary fibrosis.&#xD;
&#xD;
      D) Honeycombing: (Yes/No/Indeterminate) defined on CT as clustered cystic air spaces,&#xD;
      typically of comparable diameters on the ordered of 3-10 mm but occasionally as large as 2.5&#xD;
      cm.&#xD;
&#xD;
      Pattern: The overall pattern/Type of ILA findings will also be scored as the following:&#xD;
      Subpleural, centrilobular, mixed or consistent with ILD (see UIP below).&#xD;
&#xD;
      Subpleural: Defined as less than 1 cm from the pleural surface.&#xD;
&#xD;
      Centrilobular: Defined as region of the bronchiolovascular core of the secondary pulmonary&#xD;
      lobule.&#xD;
&#xD;
      Location: Overall location ILA will then be scored as Upper lobe, lower lobe or diffuse.&#xD;
&#xD;
      Extent: Overall extent of disease will be scored as Mild, Moderate and Marked.&#xD;
&#xD;
      Usual Interstitial Pneumonia: Finally, the subset of scans that have evidence of fibrotic&#xD;
      disease defined as traction bronchiectasis/honeycombing will then be classified as consistent&#xD;
      with usual interstitial pneumonia (UIP) (Yes/Probable/No) based on Fleischner Criteria. UIP&#xD;
      defined as Honey-combing with basal and subpleural distribution.&#xD;
&#xD;
      Progression: The subset of patients who have had their T4 (5 year post baseline) screening&#xD;
      scanned will be independently scored as above and in addition will be compared to their&#xD;
      baseline scans and scored for progression: Stable, improved, and progressed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2021</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of ILA at baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Both presence and absence of ILA, as well as phenotypes, will be described for the entire cohort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Association between baseline ILA (presence/absence) and time to mortality, time to first hospitalization, and time to development of cancer in the full cohort</measure>
    <time_frame>6 months</time_frame>
    <description>Kaplan-Meier plots will be generated to visualize the associations between ILA variables and cancer, hospital admission and mortality. The log-rank test will be used to evaluate for a significant association. Cox regression proportional hazards models will be used to test for this association in both univariate and multivariable models. The multivariable model will be adjusted for age, sex, smoking status and pack years exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression of ILA</measure>
    <time_frame>6 months</time_frame>
    <description>Progression of ILA, defined as worsening of existing ILA or incidence of ILA over 5 years, will be described for the subset of patients with T4 imaging at 5 years. Univariate and multivariable analyses using logistic regression will be performed to test for associations between qualitative ILA characteristics (presence and absence, as well as individual phenotypes in separate models) and progression (yes/no). Stable and improved will be considered no progression, while incident ILA and worsening of existing ILA will be considered progression. Models will be checked for influential points. Multivariable models will be adjusted for sex, age, currently smoking, and pack years exposure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between phenotypes of ILA and outcomes</measure>
    <time_frame>6 months</time_frame>
    <description>Using Kaplan-Meier plots and Cox regression analysis to examine association between phenotypes of ILA with time to first hospitalization, cancer, and mortality. The proportional hazards assumption will be checked for all Cox regression models.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between ILA and time to cause-specific mortality, hospitalization.</measure>
    <time_frame>6 months</time_frame>
    <description>Investigators will investigate the association between ILA (presence/absence) and time to cause-specific mortality (pulmonary, cardiac, cancer, other), as well as cause-specific hospitalization based on primary diagnosis (COPD, PNA, and CHF). The proportional hazards assumption will be checked for all Cox regression models.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1703</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <condition>IPF</condition>
  <arm_group>
    <arm_group_label>CT Lung Cancer Screening Patients</arm_group_label>
    <description>All CT Lung Cancer Screening patients at LHMC from January 1st, 2012 to September 30th, 2014 with an in-network PCP that had baseline CT scans will be scored. A subset of these patients with T4 screening scans will be scored for progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrospective observational study</intervention_name>
    <description>No intervention to occur</description>
    <arm_group_label>CT Lung Cancer Screening Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All clinical CTLS patients at Lahey Hospital and Medical Center (LHMC), Burlington, MA from&#xD;
        January 1st, 2012 through September 30th, 2014 who had an in network primary care physician&#xD;
        (n=1703). Patients with T4 screening scans will be scored for progression (n=653). To&#xD;
        qualify for our study, patients had to satisfy the National Comprehensive Cancer Network&#xD;
        (NCCN) Guidelines® Lung Cancer Screening Version 1.2012 high-risk criteria for lung cancer.&#xD;
        Based on the NCCN Guidelines®, individuals eligible for lung cancer screening can be&#xD;
        classified into NCCN group 1 and 2 as previously described.21 Patients in both groups were&#xD;
        asymptomatic and had a physician order for CTLS, were free of lung cancer for ≥ 5 years,&#xD;
        and had no known metastatic disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Patient who have undergone low-dose screening CT scan for lung cancer&#xD;
        as part of the LHMC CTLS program from January 1, 2012 through September 30, 2014, with an&#xD;
        in-network PCP.&#xD;
&#xD;
        Exclusion Criteria: Any patient that does not meet inclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee Gazourian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lahey Hospital &amp; Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lahey Hospital and Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.</citation>
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  <reference>
    <citation>National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.</citation>
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  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lahey Clinic</investigator_affiliation>
    <investigator_full_name>Lee Gazourian</investigator_full_name>
    <investigator_title>Director of Quantitative Analysis</investigator_title>
  </responsible_party>
  <keyword>Interstitial Lung Disease</keyword>
  <keyword>Interstitial Lung Abnormalities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</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/NCT04503044
org study id: 1628689
nct id: NCT04503044
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Interstitial Lung Abnormalities (ILA) have been previously defined as nondependent changes
      affecting more than 5% of any lung zone on computed tomography (CT) scans of the lung.
      Several studies suggest that the prevalence of ILA in participants in non-pulmonary research
      studies ranges anywhere from 7-9%. Work over the last decade has shown that, despite previous
      characterization as an asymptomatic research finding, ILA has significant clinical and
      biological consequences. These include reduced exercise capacity, functional limitations,
      decreased lung volumes, increased mortality, and in some cases histopathology similar to
      Idiopathic Pulmonary Fibrosis (IPF). ILA have been detected in lung cancer screening cohorts,
      where the prevalence of ILA is estimated to be between (10%-20%) to those noted in other
      research cohorts. Given that a significant proportion of those will have progression, CT lung
      cancer screening (CTLS) cohorts represent an ideal catchment population for future research
      and clinical trials. Lahey Hospital and Medical Center was one of the earliest clinical
      centers to develop a CTLS program in the country. Investigators propose to qualitatively
      characterize ILA in a large clinical CTLS population.
Investigators propose a retrospective, single-center study with following aims:

        1. Characterize the prevalence and incidence of ILA at baseline and 5 year follow-up,
           respectively, and associated imaging phenotypes in CTLS cohort.

        2. Baseline qualitative ILA features associated with clinical outcomes: Lung Cancer,
           Hospitalization, and Mortality.

        3. Baseline qualitative ILA features associated with progressive ILA and fibrotic lung
           disease.

        4. Clinical opportunity: to determine the % of CTLS patients with ILA who are at risk for
           progressive and development of fibrotic lung disease and who would benefit from
           specialized care referral and potential enrollment in clinical trials utilizing proven
           antifibrotic therapies

      Patient Selection:

      All clinical CT Lung Cancer Screening (CTLS) patients at Lahey Hospital and Medical Center
      (LHMC), Burlington, MA from January 1st, 2012 through September 30th, 2014 who had an in
      network primary care physician (n=1703). Patients with T4 screening scans will be scored for
      progression (n=653). To qualify for our study, patients had to satisfy the National
      Comprehensive Cancer Network (NCCN) Guidelines® Lung Cancer Screening Version 1.2012
      high-risk criteria for lung cancer. Based on the NCCN Guidelines®, individuals eligible for
      lung cancer screening can be classified into NCCN group 1 and 2 as previously described.
      Patients in both groups were asymptomatic and had a physician order for CTLS, were free of
      lung cancer for ≥ 5 years, and had no known metastatic disease.

      Clinical Variables:

      Clinical variables were collected prospectively as part of the CTLS program and stored in a
      centralized data repository. Additional clinical variables not already available in this data
      repository will be collected retrospectively by manual review of the electronic medical
      record or pulled directly from the EMR and stored utilizing a custom-designed database
      (FileMaker ProVersion 11; Filemaker Inc, Santa Clara, California). Data was obtained through
      September 30th, 2019, patient demographics, past medical history, PFTs, immunization records,
      whether the patient was managed by a pulmonologist, and for hospital admissions with
      principal admission diagnoses. Hospital admissions will be collected using Lahey
      administrative coding data. Principal admission diagnoses of COPD, PNA, and CHF will be
      characterized based on diagnosis codes per 2018 Center for Medicare and Medicaid Services
      (CMS) condition-specific measures.

      CT Imaging:

      Clinically acquired, CTLS examinations which were performed on ≥64-row multidetector CT
      scanners (LightSpeed VCT and Discovery VCT [GE Medical Systems, Milwaukee, Wisconsin];
      Somatom Definition [Siemens AG, Erlangen, Germany]; iCT [Philips Medical Systems, Andover,
      Massachusetts]) at 100 kV and 30 to 100 mA, depending on the scanner and the availability of
      iterative reconstruction software. Axial images were obtained at 1.25- to 1.5-mm thickness
      with 50% overlap and reconstructed with both soft tissue and lung kernels.

      Qualitative ILA Scoring:

      CT images will be scored utilizing Philips Intellispace PACS version 4.4 with clinical grade
      monitors. Scoring will be performed independently by two thoracic radiologists as described
      previously. Scores that are discordant between the two radiologists will be scored by a third
      by a pulmonologist with expertise in ILD.

      ILA: The presence of ILA features will be scores as (Yes/No/Indeterminate). Indeterminate
      will be defined as features identified unilaterally/focal involvement.

      ILA features that will be scored include: A) non dependent ground glass, B) reticular
      abnormalities, C) traction bronchiectasis and D) honeycombing.

      A) Non Dependent ground glass: (Yes/No/Indeterminate) defined as hazy increased attenuation
      of the lung with preservation of bronchial and vascular margins.

      B) Reticular abnormalities: (Yes/No/Indeterminate) defined as a collection of innumerable
      small linear opacities that, by summation, produce an appearance resembling a net.

      C) Traction Bronchiectasis: (Yes/No/Indeterminate) defined Traction bronchiectasis and
      traction bronchiolectasis respectively represents irregular bronchial and bronchiolar
      dilatation caused by surrounding retractile pulmonary fibrosis.

      D) Honeycombing: (Yes/No/Indeterminate) defined on CT as clustered cystic air spaces,
      typically of comparable diameters on the ordered of 3-10 mm but occasionally as large as 2.5
      cm.

      Pattern: The overall pattern/Type of ILA findings will also be scored as the following:
      Subpleural, centrilobular, mixed or consistent with ILD (see UIP below).

      Subpleural: Defined as less than 1 cm from the pleural surface.

      Centrilobular: Defined as region of the bronchiolovascular core of the secondary pulmonary
      lobule.

      Location: Overall location ILA will then be scored as Upper lobe, lower lobe or diffuse.

      Extent: Overall extent of disease will be scored as Mild, Moderate and Marked.

      Usual Interstitial Pneumonia: Finally, the subset of scans that have evidence of fibrotic
      disease defined as traction bronchiectasis/honeycombing will then be classified as consistent
      with usual interstitial pneumonia (UIP) (Yes/Probable/No) based on Fleischner Criteria. UIP
      defined as Honey-combing with basal and subpleural distribution.

      Progression: The subset of patients who have had their T4 (5 year post baseline) screening
      scanned will be independently scored as above and in addition will be compared to their
      baseline scans and scored for progression: Stable, improved, and progressed.
observational model: Cohort
time perspective: Retrospective
measure: Prevalence of ILA at baseline
time frame: 6 months
description: Both presence and absence of ILA, as well as phenotypes, will be described for the entire cohort.
measure: Association between baseline ILA (presence/absence) and time to mortality, time to first hospitalization, and time to development of cancer in the full cohort
time frame: 6 months
description: Kaplan-Meier plots will be generated to visualize the associations between ILA variables and cancer, hospital admission and mortality. The log-rank test will be used to evaluate for a significant association. Cox regression proportional hazards models will be used to test for this association in both univariate and multivariable models. The multivariable model will be adjusted for age, sex, smoking status and pack years exposure.
measure: Progression of ILA
time frame: 6 months
description: Progression of ILA, defined as worsening of existing ILA or incidence of ILA over 5 years, will be described for the subset of patients with T4 imaging at 5 years. Univariate and multivariable analyses using logistic regression will be performed to test for associations between qualitative ILA characteristics (presence and absence, as well as individual phenotypes in separate models) and progression (yes/no). Stable and improved will be considered no progression, while incident ILA and worsening of existing ILA will be considered progression. Models will be checked for influential points. Multivariable models will be adjusted for sex, age, currently smoking, and pack years exposure.
measure: Association between phenotypes of ILA and outcomes
time frame: 6 months
description: Using Kaplan-Meier plots and Cox regression analysis to examine association between phenotypes of ILA with time to first hospitalization, cancer, and mortality. The proportional hazards assumption will be checked for all Cox regression models.
measure: Association between ILA and time to cause-specific mortality, hospitalization.
time frame: 6 months
description: Investigators will investigate the association between ILA (presence/absence) and time to cause-specific mortality (pulmonary, cardiac, cancer, other), as well as cause-specific hospitalization based on primary diagnosis (COPD, PNA, and CHF). The proportional hazards assumption will be checked for all Cox regression models.
arm group label: CT Lung Cancer Screening Patients
description: All CT Lung Cancer Screening patients at LHMC from January 1st, 2012 to September 30th, 2014 with an in-network PCP that had baseline CT scans will be scored. A subset of these patients with T4 screening scans will be scored for progression.
intervention type: Other
intervention name: Retrospective observational study
description: No intervention to occur
arm group label: CT Lung Cancer Screening Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lee Gazourian, MD
role: Principal Investigator
affiliation: Lahey Hospital & Medical Center
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Lahey Clinic
investigator full name: Lee Gazourian
investigator title: Director of Quantitative Analysis
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
sharing ipd: No