NCT03515863

Natural History and Risk Factors of TAO

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Associated Ophthalmopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-05-15
• Primary completion: 2021-05-09
• Completion: 2022-05-09
• First posted: 2018-05-04
• Last updated: 2019-09-23

Locations

2 sites across 1 country: China