<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/NCT02231996</url>
  </required_header>
  <id_info>
    <org_study_id>CGD-20140829</org_study_id>
    <nct_id>NCT02231996</nct_id>
  </id_info>
  <brief_title>Chronic Granulomatous Disease Study in China</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Children's Medical Center</source>
  <brief_summary>
    <textblock>
      CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the&#xD;
      subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who are&#xD;
      diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine,&#xD;
      including clinical feature, laboratory data and genetic information. we aim to find out&#xD;
      clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus&#xD;
      further improving the level of diagnosis and treatment for CGD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>times of pneumonia</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Granulomatous Disease, Chronic</condition>
  <arm_group>
    <arm_group_label>gene mutation</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        CGD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  x-linked and AR-linked Chronic Granulomatous Disease&#xD;
&#xD;
          -  history of life-threatening severe infections&#xD;
&#xD;
          -  A functional assay demonstrating abnormal NADPH oxidase function or clinical history&#xD;
             consistent with CGD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of other primary immunodeficiency syndromes that do not meet the clinical and&#xD;
             laboratory criteria for CGD.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>jing wu</last_name>
    <email>wujingecnu@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai children's medical center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Granuloma</mesh_term>
    <mesh_term>Granulomatous Disease, Chronic</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/NCT02231996
org study id: CGD-20140829
nct id: NCT02231996
lead sponsor: 
CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the
      subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who are
      diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine,
      including clinical feature, laboratory data and genetic information. we aim to find out
      clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus
      further improving the level of diagnosis and treatment for CGD.
observational model: Cohort
time perspective: Prospective
measure: times of pneumonia
time frame: 2 years
arm group label: gene mutation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: jing wu
email: wujingecnu@163.com
facility: 
country: China
responsible party type: Sponsor
mesh term: Granuloma
mesh term: Granulomatous Disease, Chronic