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Natural History and Risk Factors of TAO

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ClinicalTrials.gov Identifier: NCT03515863
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yingfeng Zheng, Sun Yat-sen University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Thyroid Associated Ophthalmopathy Genetic: DNA extraction and genetic characterization Device: Orbit MRI examination Other: Collection of life style data

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Natural History and Genetic Risk Factors of Thyroid Associated Ophthalmopathy (TAO)
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 9, 2021
Estimated Study Completion Date : May 9, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Grave's disease with TAO
Patients with Grave's disease and TAO
 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
Grave's disease without TAO
Patients with Grave's disease but without TAO
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cellular biomarkers for risk of TAO [ Time Frame: 1 year ]
    Cellular biomarkers for risk of TAO are identified by transcriptomics and mass cytometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515863


Contacts
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Contact: Yingfeng Zheng +8613922286455 zhyfeng@mail.sysu.edu.cn

Locations
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China
Zhognshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, China
Contact: Yizhi Liu         
the First People's Hospital of Zhaoqing Recruiting
Zhaoqing, China
Contact: Haobo Chen         
Sponsors and Collaborators
Sun Yat-sen University
More Information
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Responsible Party: Yingfeng Zheng, Clinical investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03515863    
Other Study ID Numbers: 2017KYPJ123
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
 Orbital Diseases
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases