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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03515863
Other study ID # 2017KYPJ123
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT03107078 - Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial Phase 4
Recruiting NCT04548284 - Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO Phase 3
Not yet recruiting NCT06392906 - Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial) Phase 3
Recruiting NCT06226545 - A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease Phase 2
Completed NCT00150111 - Rituximab in the Treatment of Graves' Disease Phase 1/Phase 2
Completed NCT03110848 - Effects of Atorvastatin in Graves' Orbitopathy (GO) Phase 2
Recruiting NCT04662190 - Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery. N/A
Active, not recruiting NCT05276063 - A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Not yet recruiting NCT04919694 - Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy N/A
Recruiting NCT03131726 - Treatment of Graves´Ophthalmopathy With Simvastatin (GO-S) Phase 3
Completed NCT02766660 - Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy N/A
Active, not recruiting NCT06269393 - A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy Phase 3
Not yet recruiting NCT03098225 - A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy Phase 4
Recruiting NCT05112211 - Multi-model Image of Doxycycline in TAO N/A