Natural History and Risk Factors of TAO

Sun Yat-sen University400 enrolled

Overview

The aim of this study is to complete the identification of genetic factors predisposing to thyroid associated ophthalmopathy (TAO) by constituting a cohort of 400 Grave's patients with or without ocular signs.

Graves' disease (GD) is a common autoimmune condition, and its ocular condition is known as thyroid-associated ophthalmopathy (TAO). There is considerable evidence that both genetic and environmental factors are involved in the development of TAO. We conduct a study of 400 Grave's patients, with or without TAO, and obtain the following data: genetic tests, ocular imaging and life style information. Genetic tests are obtained by collection of blood samples for DNA extraction, whole-genome sequencing, and identification of cellular biomarkers, using transcriptomics and mass cytometry. Ocular imaging data are collected from Orbit MRI examination. Life style data are collected using a standardized questionnaire.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Thyroid Associated Ophthalmopathy

Interventions

DNA extraction and genetic characterizationGENETIC

Collection of blood samples for DNA extraction and genetic characterization using whole-genome sequencing, and for identification of cellular biomarkers using transcriptomics and mass cytometry.

Orbit MRI examinationDEVICE

Orbit MRI examination is performed to confirm the diagnosis of TAO

Collection of life style dataOTHER

Collection of life style data using quality of life questionnaire

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients of Grave's disease with the history of more than 1 years 2. Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study Exclusion Criteria: 1. Pregnancy (positive test) or lactation 2. Participating in another simultaneous medical investigation or clinical trial within 3 months 3. Having received cellular therapy 4. With a history of psychotropic drugs abuse 5. With a history of mental disorder 6. With a history of malignant tumor 7. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent

Locations (2)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, China

RECRUITING

the First People's Hospital of Zhaoqing

Zhaoqing, China

RECRUITING

Outcomes

Primary Outcomes

Genetic risk factors of TAO predisposition

Genetic risk factors of TAO are identified by pathogenic gene screening using the whole-genome sequencing of peripheral blood cells.

Time frame: 1 year

Secondary Outcomes

Cellular biomarkers for risk of TAO

Cellular biomarkers for risk of TAO are identified by transcriptomics and mass cytometry

Time frame: 1 year

Central Contacts

Yingfeng Zheng

CONTACT

+8613922286455 zhyfeng@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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