Natural History and Genetic Risk Factors of Thyroid Associated Ophthalmopathy (TAO)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Genetic risk factors of TAO predisposition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of Grave's disease with the history of more than 1 years
- •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
排除标准
- •Pregnancy (positive test) or lactation
- •Participating in another simultaneous medical investigation or clinical trial within 3 months
- •Having received cellular therapy
- •With a history of psychotropic drugs abuse
- •With a history of mental disorder
- •With a history of malignant tumor
- •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
结局指标
主要结局
Genetic risk factors of TAO predisposition
时间窗: 1 year
Genetic risk factors of TAO are identified by pathogenic gene screening using the whole-genome sequencing of peripheral blood cells.
次要结局
- Cellular biomarkers for risk of TAO(1 year)
研究者
Yingfeng Zheng
Clinical investigator
Sun Yat-sen University