<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/NCT03282383</url>
  </required_header>
  <id_info>
    <org_study_id>Severe pneumonia biomarkers</org_study_id>
    <nct_id>NCT03282383</nct_id>
  </id_info>
  <brief_title>Identification of Biomarkers for Severe Pneumonia</brief_title>
  <official_title>Shanghai Changhai Hospital,Second Military Medical University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai Hospital</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 identify the potential serum biomarkers with regard to the severity of pneumonia, and to&#xD;
      further evaluate the prognostic value of these markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      First, we will collect serum samples from patients with pneumonia. Then we will identify&#xD;
      biomarkers differentially expressed between non-severe pneumonia and severe pneumonia. We&#xD;
      will further evaluate the prognostic value of these markers for pneumonia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>microRNA</measure>
    <time_frame>3 years</time_frame>
    <description>the all of microRNA of blood plasma</description>
  </primary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Biomarkers</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        collection the blood from 600 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - under 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  over 80 years old&#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>Xiangyu Kong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Xiangyu Kong</investigator_full_name>
    <investigator_title>changhai hospital</investigator_title>
  </responsible_party>
  <keyword>biomarkers pneumonia severity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</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/NCT03282383
org study id: Severe pneumonia biomarkers
nct id: NCT03282383
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To identify the potential serum biomarkers with regard to the severity of pneumonia, and to
      further evaluate the prognostic value of these markers.
First, we will collect serum samples from patients with pneumonia. Then we will identify
      biomarkers differentially expressed between non-severe pneumonia and severe pneumonia. We
      will further evaluate the prognostic value of these markers for pneumonia.
observational model: Case-Crossover
time perspective: Prospective
measure: microRNA
time frame: 3 years
description: the all of microRNA of blood plasma
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiangyu Kong, MD
role: Principal Investigator
affiliation: Changhai Hospital
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Xiangyu Kong
investigator title: changhai hospital
mesh term: Pneumonia