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Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT02210741
Collaborator
(none)
200
Enrollment
1
Location
114
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease
    Study Start Date :
    Aug 1, 2014
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients [Three years]

      "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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Patients with Graves disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei City Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Tien-Chun Chang, Professor of Department of Internal Medicine, National Taiwan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02210741
    Other Study ID Numbers:
    • 201312091RINB
    First Posted:
    Aug 7, 2014
    Last Update Posted:
    Aug 7, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by National Taiwan University Hospital
    immune repertoire
    Graves' disease
    Additional relevant MeSH terms:
    Graves Disease

    Study Results

    No Results Posted as of Aug 7, 2014