Natural History and Risk Factors of TAO

Thyroid Associated Ophthalmopathy Clinical Trial

Official title:

Natural History and Genetic Risk Factors of Thyroid Associated Ophthalmopathy (TAO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03515863
• Other study ID #: 2017KYPJ123
• Status: Recruiting
• Start date: May 15, 2018
• Est. completion date: May 9, 2022

Study information

• Verified date: September 2019
• Source: Sun Yat-sen University
• Contact: Yingfeng Zheng
• Phone: +8613922286455
• Email: zhyfeng[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Associated Ophthalmopathy
• Thyroid Diseases

Intervention

Genetic:
• DNA extraction and genetic characterization
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.

Device:
• Orbit MRI examination
Orbit MRI examination is performed to confirm the diagnosis of TAO

Other:
• Collection of life style data
Collection of life style data using quality of life questionnaire

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou
China	the First People's Hospital of Zhaoqing	Zhaoqing

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Cellular biomarkers for risk of TAO	Cellular biomarkers for risk of TAO are identified by transcriptomics and mass cytometry	1 year