<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/NCT03240315</url>
  </required_header>
  <id_info>
    <org_study_id>201604020012</org_study_id>
    <secondary_id>2017YFC1310600</secondary_id>
    <nct_id>NCT03240315</nct_id>
  </id_info>
  <brief_title>Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Establishment of Individualized Prediction System for Acute Exacerbation of Chronic Obstructive Pulmonary Disease Based on Cloud Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Institute of Respiratory Disease</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangzhou Science and Technology Innovation Commission,China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou Institute of Respiratory Disease</source>
  <brief_summary>
    <textblock>
      This is a 3 year longitudinal study to establish a personalized prediction and prevention&#xD;
      system for acute exacerbation of chronic obstructive pulmonary disease（AECOPD). Data will be&#xD;
      collected which contained with clinical, pathophysiology, etiology and immunology information&#xD;
      of chronic obstructive pulmonary disease(COPD) patients and analyzed by data mining combined&#xD;
      with Internet technology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">June 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Establishment of prediction platform for COPD exacerbation</measure>
    <time_frame>3 years</time_frame>
    <description>The patients with chronic obstruction pulmonary disease will be followed up at intervals of 3 months for 3 years by the Modified British Medical Research Council (mMRC) score scale,spirometric analysis, sputum smear,questionnaire and so on. An exacerbation of COPD was diagnosed according to GOLD guidelines. Time to the first acute exacerbation and average number of acute exacerbations per year in COPD subjects will be record.Research of AECOPD Risk factors based on complex network analysis.Identification and validation of COPD exacerbations risk stratification and predictive markers based on data mining.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Developing new protein chips for AECOPD</measure>
    <time_frame>3 years</time_frame>
    <description>Systemic and airway autoantibody profiles and cytokine profiles will be measured using commercial multiplex bead-based assay to screen out a set of ideal AECOPD-related markers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of immune repertoire in COPD/AECOPD</measure>
    <time_frame>3 years</time_frame>
    <description>Immune status of COPD patients will be investigated by using the immune repertoire technique and its relationship with the pathophysiology of AECOPD will be identified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathogenic microorganism and drug resistance monitoring for COPD exacerbation</measure>
    <time_frame>3 years</time_frame>
    <description>Dynamics of pathogenic microorganism and drug resistance in natural course of COPD will be investigated by using the metagenome technique and the culture technique.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>COPD subjects</arm_group_label>
    <description>Subjects with GOLD stage I-IV COPD</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, serum, plasma,sputum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        COPD subjects in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive&#xD;
             Lung Disease (GOLD) guidelines older than 40 years old.&#xD;
&#xD;
               -  A signed and dated written informed consent is obtained prior to participation.&#xD;
&#xD;
               -  Able to comply with the requirements of the protocol and be available for study&#xD;
                  visits over 3 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A COPD subject will not be eligible for inclusion in this study if any of the&#xD;
             following criteria apply:&#xD;
&#xD;
               -  Known respiratory disorders, or disorders identified at screening/visit 1&#xD;
                  (including identification on the first CT scan), other than COPD (e.g.: lung&#xD;
                  cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)&#xD;
&#xD;
               -  Known history of significant inflammatory disease, other than COPD (e.g.&#xD;
                  rheumatoid arthritis and Lupus)&#xD;
&#xD;
               -  Known to be severely alpha-1-antitrypsin deficient&#xD;
&#xD;
               -  Has experienced a moderate or severe exacerbation (requiring oral corticosteroid,&#xD;
                  antibiotics or hospitalisation) within the last 4 weeks&#xD;
&#xD;
               -  Having undergone lung surgery (e.g. lung reduction, lung transplant)&#xD;
&#xD;
               -  Have cancer or have had cancer in the 5 years prior to study entry&#xD;
&#xD;
               -  Having received a blood transfusion in the 4 weeks prior to study start&#xD;
&#xD;
               -  Inability to walk&#xD;
&#xD;
               -  Taking part in a blinded drug study&#xD;
&#xD;
               -  Having therapy with systemic corticosteroids at inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rongchang Chen, MD/Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>February 6, 2021</last_update_submitted>
  <last_update_submitted_qc>February 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Institute of Respiratory Disease</investigator_affiliation>
    <investigator_full_name>Fengyan Wang</investigator_full_name>
    <investigator_title>Principal Investigator</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, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03240315
org study id: 201604020012
secondary id: 2017YFC1310600
nct id: NCT03240315
lead sponsor: 
collaborator: 
collaborator: 
This is a 3 year longitudinal study to establish a personalized prediction and prevention
      system for acute exacerbation of chronic obstructive pulmonary disease（AECOPD). Data will be
      collected which contained with clinical, pathophysiology, etiology and immunology information
      of chronic obstructive pulmonary disease(COPD) patients and analyzed by data mining combined
      with Internet technology.
observational model: Cohort
time perspective: Prospective
measure: Establishment of prediction platform for COPD exacerbation
time frame: 3 years
description: The patients with chronic obstruction pulmonary disease will be followed up at intervals of 3 months for 3 years by the Modified British Medical Research Council (mMRC) score scale,spirometric analysis, sputum smear,questionnaire and so on. An exacerbation of COPD was diagnosed according to GOLD guidelines. Time to the first acute exacerbation and average number of acute exacerbations per year in COPD subjects will be record.Research of AECOPD Risk factors based on complex network analysis.Identification and validation of COPD exacerbations risk stratification and predictive markers based on data mining.
measure: Developing new protein chips for AECOPD
time frame: 3 years
description: Systemic and airway autoantibody profiles and cytokine profiles will be measured using commercial multiplex bead-based assay to screen out a set of ideal AECOPD-related markers.
measure: Detection of immune repertoire in COPD/AECOPD
time frame: 3 years
description: Immune status of COPD patients will be investigated by using the immune repertoire technique and its relationship with the pathophysiology of AECOPD will be identified.
measure: Pathogenic microorganism and drug resistance monitoring for COPD exacerbation
time frame: 3 years
description: Dynamics of pathogenic microorganism and drug resistance in natural course of COPD will be investigated by using the metagenome technique and the culture technique.
arm group label: COPD subjects
description: Subjects with GOLD stage I-IV COPD
Whole blood, serum, plasma,sputum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Rongchang Chen, MD/Ph.D
role: Study Director
affiliation: Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Institute of Respiratory Disease
investigator full name: Fengyan Wang
investigator title: Principal Investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No