Natural History and Risk Factors of TAO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-15

Study Completion Date

2022-05-09

Brief Summary

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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.

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Detailed Description

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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

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Thyroid Associated Ophthalmopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Grave's disease with TAO

Patients with Grave's disease and TAO

DNA extraction and genetic characterization

Intervention Type GENETIC

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.

Orbit MRI examination

Intervention Type DEVICE

Orbit MRI examination is performed to confirm the diagnosis of TAO

Collection of life style data

Intervention Type OTHER

Collection of life style data using quality of life questionnaire

Grave's disease without TAO

Patients with Grave's disease but without TAO

DNA extraction and genetic characterization

Intervention Type GENETIC

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.

Orbit MRI examination

Intervention Type DEVICE

Orbit MRI examination is performed to confirm the diagnosis of TAO

Collection of life style data

Intervention Type OTHER

Collection of life style data using quality of life questionnaire

Interventions

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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.

Intervention Type GENETIC

Orbit MRI examination

Orbit MRI examination is performed to confirm the diagnosis of TAO

Intervention Type DEVICE

Collection of life style data

Collection of life style data using quality of life questionnaire

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No