Clinical trial NCT03515863: Natural History and Risk Factors of TAO
Official title: Natural History and Genetic Risk Factors of Thyroid Associated Ophthalmopathy (TAO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Associated Ophthalmopathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TAO Patients:

Patients who are diagnosed as Grave's disease and TAO are enrolled into the study from 2 clinical centers. This diagnosis is made according to classical criteria of TAO, including thyroid function testing, ocular examination and orbit MRI examination.

Control:

Patients who are diagnosed as Grave's disease but without ocular signs are enrolled into the study from 2 clinical centers. This diagnosis of Grave's disease is made according to classical criteria including thyroid function testing. Ocular signs are excluded by routine ocular examination and orbit MRI examination.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Genetic risk factors of TAO predisposition
timeFrame: 1 year
Secondary outcomes:
measure: Cellular biomarkers for risk of TAO
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
city: Zhaoqing
country: China
facility: the First People's Hospital of Zhaoqing
Study officials:
References: