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

Graves Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02210741
• Other study ID #: 201312091RINB
• Status: Not yet recruiting
• Phase: N/A
• First received: August 4, 2014
• Last updated: August 5, 2014
• Start date: August 2014
• Est. completion date: February 2024

Study information

• Verified date: August 2014
• Source: National Taiwan University Hospital
• Contact: Pei-Lung Chen
• Phone: 886-2-23123456
• Email: paylong[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older
• Eligibility: Patients with Graves disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Graves Disease

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients	"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.	Three years	No