xml: <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/NCT05999838</url>
    </required_header>
    <id_info>
      <org_study_id>HR chest CT spirometry ILD</org_study_id>
      <nct_id>NCT05999838</nct_id>
    </id_info>
    <brief_title>HR Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of ILD Patients</brief_title>
    <official_title>High-resolution Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of Interstitial Lung Disease Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To establish a simplified approach for assessment of severity of interstitial lung disease by&#xD;
        evaluating the relationship between HRCT findings, the clinical severity score,spirometry and&#xD;
        quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The interstitial lung diseases are a group of parenchymal pulmonary disorders that affect the&#xD;
        interstitium causing progressive fibrosis of lung tissue. These disorders characterized by&#xD;
        dyspnea aggravated by exertion . This group of diseases is associated with substantial&#xD;
        morbidity and mortality. Thus, a multi-disciplinary approach including clinical,&#xD;
        pathological, and radiological correlation is required to reach accurate assessment. The&#xD;
        high-resolution computed tomography [HRCT] images of the chest are considered the main&#xD;
        platform for the diagnostic approach .High-resolution CT (HRCT) scans offer the possibility&#xD;
        of measuring disease severity more accurately and sensitively by focusing on fibrotic&#xD;
        changes. HRCT images illustrate the presence and extent of parenchymal abnormalities&#xD;
        including: reticular opacities, ground-glass opacities, traction bronchiectasis and&#xD;
        honeycombing. Most patients with suspected ILDs are likely to undergo complete Pulmonary&#xD;
        Function Testing. Usually there is restrictive pulmonary function with decreased TLC (Total&#xD;
        Lung Capacity) , FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in One Second)&#xD;
        and a normal or increased FEV1/FVC ratio.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation of visual based scoring system of HRCT and pulmonary function test.</measure>
      <time_frame>1 year</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>assessment of ILDs patients quality of life and correlation with HRCT finding and PFTs.</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Interstitial Lung Disease</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>HRCT chest visual scoring</intervention_name>
      <description>CT-based semi-quantitative scoring will be calculated according to number of lung segments affected on both sides.&#xD;
  The finding on each segment will be given a score from 1 to 4 as follows:&#xD;
  for ground glass opacities.&#xD;
  for reticulations and fibrotic changes.&#xD;
  for bronchiectatic changes.&#xD;
  for honeycombing and sub-pleural cysts.</description>
      <other_name>spirometry</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients admitted at Chest Department or presented to our out patient clinic with&#xD;
          clinical diagnosis of Interstitial Lung Diseases&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients admitted at Chest Department or presented to our out patient clinic with&#xD;
               clinical diagnosis of Interstitial Lung Diseases among both sexes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients under 18 years old.&#xD;
  &#xD;
            -  pregnant patients.&#xD;
  &#xD;
            -  patients with a history of previous lung resections.&#xD;
  &#xD;
            -  presence of bronchial carcinoma or lobar consolidation.&#xD;
  &#xD;
            -  patients contraindicated to perform pulmonary function will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Dina W. Fahim, resident doctor</last_name>
      <phone>01287799134</phone>
      <email>tinawageh0@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nermeen M. Abu Elkassem, Lecturer</last_name>
      <phone>01000767713</phone>
      <email>nermenabuelkassem@gmail.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Dina Wageeh Fahim</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </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, Interstitial</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999838
  org study id: HR chest CT spirometry ILD
  nct id: NCT05999838
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To establish a simplified approach for assessment of severity of interstitial lung disease by
        evaluating the relationship between HRCT findings, the clinical severity score,spirometry and
        quality of life.
  The interstitial lung diseases are a group of parenchymal pulmonary disorders that affect the
        interstitium causing progressive fibrosis of lung tissue. These disorders characterized by
        dyspnea aggravated by exertion . This group of diseases is associated with substantial
        morbidity and mortality. Thus, a multi-disciplinary approach including clinical,
        pathological, and radiological correlation is required to reach accurate assessment. The
        high-resolution computed tomography [HRCT] images of the chest are considered the main
        platform for the diagnostic approach .High-resolution CT (HRCT) scans offer the possibility
        of measuring disease severity more accurately and sensitively by focusing on fibrotic
        changes. HRCT images illustrate the presence and extent of parenchymal abnormalities
        including: reticular opacities, ground-glass opacities, traction bronchiectasis and
        honeycombing. Most patients with suspected ILDs are likely to undergo complete Pulmonary
        Function Testing. Usually there is restrictive pulmonary function with decreased TLC (Total
        Lung Capacity) , FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in One Second)
        and a normal or increased FEV1/FVC ratio.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Correlation of visual based scoring system of HRCT and pulmonary function test.
  time frame: 1 year
  measure: assessment of ILDs patients quality of life and correlation with HRCT finding and PFTs.
  time frame: 1 year
  intervention type: Diagnostic Test
  intervention name: HRCT chest visual scoring
  description: CT-based semi-quantitative scoring will be calculated according to number of lung segments affected on both sides.
  The finding on each segment will be given a score from 1 to 4 as follows:
  for ground glass opacities.
  for reticulations and fibrotic changes.
  for bronchiectatic changes.
  for honeycombing and sub-pleural cysts.
  other name: spirometry
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Dina W. Fahim, resident doctor
  phone: 01287799134
  email: tinawageh0@gmail.com
  last name: Nermeen M. Abu Elkassem, Lecturer
  phone: 01000767713
  email: nermenabuelkassem@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Dina Wageeh Fahim
  investigator title: Doctor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial