<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/NCT02210741</url>
  </required_header>
  <id_info>
    <org_study_id>201312091RINB</org_study_id>
    <nct_id>NCT02210741</nct_id>
  </id_info>
  <brief_title>Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease</brief_title>
  <official_title>Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence&#xD;
      of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic&#xD;
      predisposition. Despite its clinical and scientific significance, Graves' disease is still&#xD;
      mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune&#xD;
      repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a&#xD;
      snapshot and a historical record of a person's immune function. Thanks to the power of&#xD;
      next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell&#xD;
      receptors suddenly becomes plausible, and opens a door for many creative approaches to study&#xD;
      immune related diseases. The ultimate goal of this project is to use both the NGS deep&#xD;
      sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine&#xD;
      mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore,&#xD;
      using the immune repertoire approach, investigators want to study the critical epitopes of&#xD;
      thyroid auto-antigens, and to delineate the pathophysiological steps in various disease&#xD;
      stages and in various sub-groups. Investigators expect to solve the immune repertoire of&#xD;
      Graves' disease of different sub-group presentations and at various disease activity stages.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients</measure>
    <time_frame>Three years</time_frame>
    <description>&quot;B lymphocyte and T lymphocyte receptor profiles&quot; mean the sequence of the receptors and also the quantity of the lymphocytes with those specific receptor sequences.</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Graves Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient from our hospital, National Taiwan University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients with Graves disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tien-Chun Chang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Department of Internal Medicine, National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pei-Lung Chen</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>71942</phone_ext>
    <email>paylong@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>immune repertoire</keyword>
  <keyword>Graves' disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graves 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/NCT02210741
org study id: 201312091RINB
nct id: NCT02210741
lead sponsor: 
has dmc: No
Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence
      of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic
      predisposition. Despite its clinical and scientific significance, Graves' disease is still
      mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune
      repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a
      snapshot and a historical record of a person's immune function. Thanks to the power of
      next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell
      receptors suddenly becomes plausible, and opens a door for many creative approaches to study
      immune related diseases. The ultimate goal of this project is to use both the NGS deep
      sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine
      mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore,
      using the immune repertoire approach, investigators want to study the critical epitopes of
      thyroid auto-antigens, and to delineate the pathophysiological steps in various disease
      stages and in various sub-groups. Investigators expect to solve the immune repertoire of
      Graves' disease of different sub-group presentations and at various disease activity stages.
observational model: Case-Only
time perspective: Prospective
measure: B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients
time frame: Three years
description: "B lymphocyte and T lymphocyte receptor profiles" mean the sequence of the receptors and also the quantity of the lymphocytes with those specific receptor sequences.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Tien-Chun Chang
role: Principal Investigator
affiliation: Professor of Department of Internal Medicine, National Taiwan University
last name: Pei-Lung Chen
phone: 886-2-23123456
phone ext: 71942
email: paylong@gmail.com
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Graves Disease