<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/NCT03023371</url>
  </required_header>
  <id_info>
    <org_study_id>IgG4-RD Group in China</org_study_id>
    <nct_id>NCT03023371</nct_id>
  </id_info>
  <brief_title>National Registry of IgG4-RD in China</brief_title>
  <official_title>National Registry of IgG4-RD in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to establish a nation-wide cohort study of IgG4-related disease&#xD;
      (IgG4-RD) in China.&#xD;
&#xD;
      Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled&#xD;
      from multi-centers around China. A online database system has been established.&#xD;
&#xD;
      Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese&#xD;
      IgG4-RD patients; the secondary endpoints including the demographic features,laboratory&#xD;
      characteristics, immunological tests, imaging and pathological features, in addition, the&#xD;
      treatment and prognosis of the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter registry study of IgG4-RD patients. Newly diagnosed IgG4-RD patients&#xD;
      will be recruited from allover the China. Inclusion criteria: patients with definite,&#xD;
      probable, or possible IgG4-RD according to the 2011 comprehensive diagnostic criteria for&#xD;
      IgG4-RD will be recruited. Exclusion criteria: patients with malignancy or other autoimmune&#xD;
      diseases are excluded.&#xD;
&#xD;
      The data will be uploaded through the platform of Chinese Rheumatology Information Platform.&#xD;
      Demographic data, initial symptoms, disease duration, history of allergy, and physical&#xD;
      examination, organ involvements, laboratory findings, radiological and pathological results,&#xD;
      as well as treatment, side effects will be recorded.&#xD;
&#xD;
      This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All&#xD;
      patients will signe informed consent.&#xD;
&#xD;
      Statistical Analysis: All parameters are described in the standard summary statistics,&#xD;
      including mean, standard deviation, minimum, and maximum. All statistical analyses will be&#xD;
      performed by SPSS.&#xD;
&#xD;
      Endpoints: The primary endpoint is to investigate the organ involvements of Chinese IgG4-RD&#xD;
      patients. The secondary endpoints including the demographic features,laboratory&#xD;
      characteristics, immunological tests, imaging and pathological features, in addition, the&#xD;
      treatment and prognosis of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</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>10 Years</target_duration>
  <primary_outcome>
    <measure>Organ involvements of Chinese IgG4-RD patients</measure>
    <time_frame>5 years</time_frame>
    <description>To calculate the percentage of organ involvements in at least 900 patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse rate of IgG4-RD patients in China</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between baseline disease activities and relapse rate.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence rate of tumor in IgG4 related disease patients in China.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ten year survival rate of patients with IgG4 related disease in China.</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The imaging features of involved organs.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">900</enrollment>
  <condition>IgG4-Related Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral blood samples from IgG4-RD patients will be saved for DNA extration and study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        IgG4-RD patients around China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Conforming to the diagnostic criteria of IgG4-RD (2011);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yunyun Fei</last_name>
    <phone>+8613681125226</phone>
    <email>feiyunyun2013@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wen Zhang</last_name>
    <email>zhangwen91@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yunyun Fei</last_name>
      <phone>+8613681125226</phone>
      <email>feiyunyun2013@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Wen Zhang</last_name>
      <email>zhangwen91@sina.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Wen Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Registry; cohort study; IgG4-related disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulin G4-Related Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03023371
org study id: IgG4-RD Group in China
nct id: NCT03023371
lead sponsor: 
has dmc: Yes
The aim of this study is to establish a nation-wide cohort study of IgG4-related disease
      (IgG4-RD) in China.

      Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled
      from multi-centers around China. A online database system has been established.

      Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese
      IgG4-RD patients; the secondary endpoints including the demographic features,laboratory
      characteristics, immunological tests, imaging and pathological features, in addition, the
      treatment and prognosis of the disease.
This is a multicenter registry study of IgG4-RD patients. Newly diagnosed IgG4-RD patients
      will be recruited from allover the China. Inclusion criteria: patients with definite,
      probable, or possible IgG4-RD according to the 2011 comprehensive diagnostic criteria for
      IgG4-RD will be recruited. Exclusion criteria: patients with malignancy or other autoimmune
      diseases are excluded.

      The data will be uploaded through the platform of Chinese Rheumatology Information Platform.
      Demographic data, initial symptoms, disease duration, history of allergy, and physical
      examination, organ involvements, laboratory findings, radiological and pathological results,
      as well as treatment, side effects will be recorded.

      This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All
      patients will signe informed consent.

      Statistical Analysis: All parameters are described in the standard summary statistics,
      including mean, standard deviation, minimum, and maximum. All statistical analyses will be
      performed by SPSS.

      Endpoints: The primary endpoint is to investigate the organ involvements of Chinese IgG4-RD
      patients. The secondary endpoints including the demographic features,laboratory
      characteristics, immunological tests, imaging and pathological features, in addition, the
      treatment and prognosis of the disease.
observational model: Cohort
time perspective: Prospective
measure: Organ involvements of Chinese IgG4-RD patients
time frame: 5 years
description: To calculate the percentage of organ involvements in at least 900 patients.
measure: Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China
time frame: 5 years
measure: Relapse rate of IgG4-RD patients in China
time frame: 5 years
measure: The correlation between baseline disease activities and relapse rate.
time frame: 5 years
measure: The incidence rate of tumor in IgG4 related disease patients in China.
time frame: 5 years
measure: Ten year survival rate of patients with IgG4 related disease in China.
time frame: 10 years
measure: The imaging features of involved organs.
time frame: 3 years
measure: The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.
time frame: 3 years
Peripheral blood samples from IgG4-RD patients will be saved for DNA extration and study.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yunyun Fei
phone: +8613681125226
email: feiyunyun2013@hotmail.com
last name: Wen Zhang
email: zhangwen91@sina.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Wen Zhang
investigator title: Professor
mesh term: Immunoglobulin G4-Related Disease
sharing ipd: Yes