<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/NCT01670695</url>
  </required_header>
  <id_info>
    <org_study_id>IgG4RD-Cohort</org_study_id>
    <nct_id>NCT01670695</nct_id>
  </id_info>
  <brief_title>A Prospective Cohort Study of IgG4RD in China</brief_title>
  <official_title>Cohort Study of Patients With IgG4-Related Disease</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>
      This is an cohort study to investigate the disease course and treatment response of patients&#xD;
      with IgG4-related disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity&#xD;
      characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and&#xD;
      elevated serum IgG4 concentration.&#xD;
&#xD;
      In this study, patients with IgG4-RD will be investigated, including clinical presentation,&#xD;
      laboratory findings and imaging study. All patients will be treated by standard care and&#xD;
      follow-uped for at least 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Anticipated">January 2032</completion_date>
  <primary_completion_date type="Anticipated">January 2032</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>Clinical Response</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>IgG4-related Disease</condition>
  <arm_group>
    <arm_group_label>IgG4-RD</arm_group_label>
    <description>Patients with IgG4-RD, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis (Mikulicz disease and Küttner's tumor), inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples (serum and plasma, with DNA)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with newly diagnosed IgG4-related disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  Age 18-75 years old with informed consent&#xD;
&#xD;
          -  Patients with IgG4-RD:&#xD;
&#xD;
               1. swelling, sclerosing and inflammatory involvement of one or more organ, including&#xD;
                  sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors,&#xD;
                  retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis,&#xD;
                  sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm,&#xD;
                  lymphadenopathy, or other inflammatory conditions;&#xD;
&#xD;
               2. elevated serum IgG4 (&gt;1.35 g/L)&#xD;
&#xD;
               3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma&#xD;
                  cell infiltration (and IgG4+ plasma cells on immunohistology when performed);&#xD;
&#xD;
               4. exclusion of other diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females planning to bear a child recently or with childbearing potential&#xD;
&#xD;
          -  Concurrent severe and/or uncontrolled and/or unstable diseases&#xD;
&#xD;
          -  Patient with malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Deptment of Rheumatology, Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fengchun Zhang</last_name>
    <role>Study Chair</role>
    <affiliation>Deptment of Rheumatology, Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hua Chen, MD</last_name>
    <phone>86-10-69158797</phone>
    <email>chen77hua@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Deptment of Rheumatology, 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>Wen Zhang, MD</last_name>
      <phone>86-10-69158795</phone>
      <email>zhangwen91@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Hua Chen, MD</last_name>
      <phone>86-10-69158797</phone>
      <email>chen77hua@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>April 7, 2017</last_update_submitted>
  <last_update_submitted_qc>April 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 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>IgG4-related disease</keyword>
  <keyword>IgG4-RD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulin G4-Related Disease</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/NCT01670695
org study id: IgG4RD-Cohort
nct id: NCT01670695
lead sponsor: 
has dmc: Yes
This is an cohort study to investigate the disease course and treatment response of patients
      with IgG4-related disease.
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity
      characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and
      elevated serum IgG4 concentration.

      In this study, patients with IgG4-RD will be investigated, including clinical presentation,
      laboratory findings and imaging study. All patients will be treated by standard care and
      follow-uped for at least 6 months.
observational model: Cohort
time perspective: Prospective
measure: Clinical Response
time frame: 6 months
description: Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.
arm group label: IgG4-RD
description: Patients with IgG4-RD, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis (Mikulicz disease and Küttner's tumor), inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions.
blood samples (serum and plasma, with DNA)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wen Zhang, MD
role: Principal Investigator
affiliation: Deptment of Rheumatology, Peking Union Medical College Hospital
last name: Fengchun Zhang
role: Study Chair
affiliation: Deptment of Rheumatology, Peking Union Medical College Hospital
last name: Hua Chen, MD
phone: 86-10-69158797
email: chen77hua@gmail.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