<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/NCT02197364</url>
  </required_header>
  <id_info>
    <org_study_id>KL-6_20140715</org_study_id>
    <nct_id>NCT02197364</nct_id>
  </id_info>
  <brief_title>The Role of KL-6 in the Clinical Diagnosis of ILD</brief_title>
  <official_title>The Role of KL-6 as a Serum Biomarker in the Clinical Diagnosis of Interstitial Lung Diseases (ILD) in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fujirebio Diagnostics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Pulmonary Hospital, Shanghai, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the&#xD;
      clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among&#xD;
      patients with ILD, and comparing them to the clinical diagnostic criteria and other&#xD;
      respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of&#xD;
      ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment&#xD;
      and after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a multi-center, double-blind clinical study, the trial is divided into two parts.&#xD;
&#xD;
      Part 1: The purpose of this part is to evaluate the role of KL-6 as a biomarker in the&#xD;
      clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among&#xD;
      patients with ILD, and comparing them to the clinical diagnostic criteria and other&#xD;
      respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic&#xD;
      obstructive pulmonary disease and healthy control group.&#xD;
&#xD;
      Part 2: The purpose of this part is to study the value of KL-6 levels in terms of ILD&#xD;
      treatment effect evaluation through the detection of serum KL-6 levels before treatment and&#xD;
      30-90 days after treatment. Treatment includes anti fibrosis, anti-inflammatory and other&#xD;
      conventional therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>The KL-6 concentration on the immune analyzer</measure>
    <time_frame>The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks</time_frame>
    <description>Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with ILD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The KL-6 concentration on the immune analyzer</measure>
    <time_frame>The serum from patients other respiratory diseases will be collected for the duration of hospital stay, an average of 4 weeks</time_frame>
    <description>Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The KL-6 concentration on the immune analyzer</measure>
    <time_frame>The serum from healthy people will be collected for the duration of physical examination, an average of 1 day</time_frame>
    <description>Detect the KL-6 concentration in serum by the use of the immune analyzer among healthy people.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of KL-6 concentration on the immune analyzer</measure>
    <time_frame>pretherapy, 30-90 days after treatment</time_frame>
    <description>Change of KL-6 concentration on the immune analyzer from pretherapy to 30-90 days after treatment among patients with ILD.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1190</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>ILD, Other respiratory diseases, Healthy control group</arm_group_label>
    <description>ILD: those with interstitial lung disease.&#xD;
Other respiratory diseases: those with other respiratory disease including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease.&#xD;
Healthy control group: those who is healthy.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The residual serums in the clinical laboratory.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The serums from clinical laboratory of Shanghai Pulmonary Hospital, Nanjing Drum Tower&#xD;
        Hospital and Beijing Chaoyang Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Serums from patients with ILD, pulmonary tuberculosis, pneumonia, bronchiectasis,&#xD;
             chronic obstructive pulmonary disease and health&#xD;
&#xD;
          -  Serums from patients with ILD: before treatment and 30-90 days after treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serums from patients with cancer&#xD;
&#xD;
          -  Serums with visible precipitate&#xD;
&#xD;
          -  Serums with floc&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Hui Ping</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Pulmonary Hospital , Tongji University</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Pulmonary Hospital, Shanghai, China</investigator_affiliation>
    <investigator_full_name>Huiping Li</investigator_full_name>
    <investigator_title>Professor,Chief of Dept. of Respiratory Medicine</investigator_title>
  </responsible_party>
  <keyword>Interstitial Lung Disease</keyword>
  <keyword>Diagnosis</keyword>
  <keyword>Krebs Von Den Lungen-6</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>
  <!-- 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/NCT02197364
org study id: KL-6_20140715
nct id: NCT02197364
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the
      clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among
      patients with ILD, and comparing them to the clinical diagnostic criteria and other
      respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of
      ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment
      and after treatment.
As a multi-center, double-blind clinical study, the trial is divided into two parts.

      Part 1: The purpose of this part is to evaluate the role of KL-6 as a biomarker in the
      clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among
      patients with ILD, and comparing them to the clinical diagnostic criteria and other
      respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic
      obstructive pulmonary disease and healthy control group.

      Part 2: The purpose of this part is to study the value of KL-6 levels in terms of ILD
      treatment effect evaluation through the detection of serum KL-6 levels before treatment and
      30-90 days after treatment. Treatment includes anti fibrosis, anti-inflammatory and other
      conventional therapies.
observational model: Cohort
time perspective: Retrospective
measure: The KL-6 concentration on the immune analyzer
time frame: The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks
description: Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with ILD.
measure: The KL-6 concentration on the immune analyzer
time frame: The serum from patients other respiratory diseases will be collected for the duration of hospital stay, an average of 4 weeks
description: Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease.
measure: The KL-6 concentration on the immune analyzer
time frame: The serum from healthy people will be collected for the duration of physical examination, an average of 1 day
description: Detect the KL-6 concentration in serum by the use of the immune analyzer among healthy people.
measure: Change of KL-6 concentration on the immune analyzer
time frame: pretherapy, 30-90 days after treatment
description: Change of KL-6 concentration on the immune analyzer from pretherapy to 30-90 days after treatment among patients with ILD.
arm group label: ILD, Other respiratory diseases, Healthy control group
description: ILD: those with interstitial lung disease.
Other respiratory diseases: those with other respiratory disease including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease.
Healthy control group: those who is healthy.
The residual serums in the clinical laboratory.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 90 Years
healthy volunteers: No
last name: Li Hui Ping
role: Principal Investigator
affiliation: Shanghai Pulmonary Hospital , Tongji University
responsible party type: Principal Investigator
investigator affiliation: Shanghai Pulmonary Hospital, Shanghai, China
investigator full name: Huiping Li
investigator title: Professor,Chief of Dept. of Respiratory Medicine
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial