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Clinical Trials/NCT03515863
NCT03515863
Unknown
Not Applicable

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

Sun Yat-sen University2 sites in 1 country400 target enrollmentMay 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Associated Ophthalmopathy
Sponsor
Sun Yat-sen University
Enrollment
400
Locations
2
Primary Endpoint
Genetic risk factors of TAO predisposition
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2018
End Date
May 9, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Yingfeng Zheng

Clinical investigator

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Genetic risk factors of TAO predisposition

Time Frame: 1 year

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

Secondary Outcomes

  • Cellular biomarkers for risk of TAO(1 year)

Study Sites (2)

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