Thyroid Associated OphthalmopathyNCT03515863
Natural History and Risk Factors of TAO
An observational study of Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Associated Ophthalmopathy
- What is being tested?
- DNA extraction and genetic characterization, Orbit MRI examination and Collection of life style data
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 15 May 2018to 9 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou
Yizhi Liu
- Recruiting
the First People's Hospital of Zhaoqing
Zhaoqing
Haobo Chen
About this study
Official title: Natural History and Genetic Risk Factors of Thyroid Associated Ophthalmopathy (TAO)
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.
Read the 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
- Being tested
- DNA extraction and genetic characterization, Orbit MRI examination, Collection of life style data
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA extraction and genetic characterizationGenetic
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 examinationDevice
Orbit MRI examination is performed to confirm the diagnosis of TAO
Collection of life style dataOther
Collection of life style data using quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Grave's disease with TAO | Patients with Grave's disease and TAO Receives: Genetic: DNA extraction and genetic characterization; Device: Orbit MRI examination; Other: Collection of life style data | |
| Grave's disease without TAO | Patients with Grave's disease but without TAO Receives: Genetic: DNA extraction and genetic characterization; Device: Orbit MRI examination; Other: Collection of life style data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Cellular biomarkers for risk of TAO
Cellular biomarkers for risk of TAO are identified by transcriptomics and mass cytometry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start15 May 2018
- Primary completion9 May 2021 (estimated)
- Study completion9 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Associated OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515863
- Sponsor's protocol ID
- 2017KYPJ123
- Status last verified
- Sep 2019
- First submitted
- 23 Apr 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Z, Ke SR, Shi ZX, Zhou M, Sun L, Sun QH, Xiao B, Wang DL, Huang YJ, Lin JS, Wang HS, Zhang QK, Pan CN, Liang XW, Chen RX, Mao Z, Lin XC. Dynamic transition of Tregs to cytotoxic phenotype amid systemic inflammation in Graves' ophthalmopathy. JCI Insight. 2024 Nov 22;9(22):e181488. doi: 10.1172/jci.insight.181488.
PubMed 39365735
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Genetic Risk Factors of Thyroid Associated Ophthalmopathy (TAO)
- ClinicalTrials.gov ID
- NCT03515863
- Acronym / sponsor ID
- 2017KYPJ123
- Conditions
- Thyroid Associated Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 9 May 2021 (estimated)
- Study completion
- 9 May 2022 (estimated)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grave's disease with TAO | – | Genetic: DNA extraction and genetic characterization, Device: Orbit MRI examination, Other: Collection of life style dataPatients with Grave's disease and TAO |
| Grave's disease without TAO | – | Genetic: DNA extraction and genetic characterization, Device: Orbit MRI examination, Other: Collection of life style dataPatients with Grave's disease but without TAO |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA extraction and genetic characterizationCollection of blood samples for DNA extraction and genetic characterization using whole-genome sequencing, and for identification of cellular biomarkers using transcriptomics and mass cytometry. | Genetic | Grave's disease with TAO, Grave's disease without TAO |
| Orbit MRI examinationOrbit MRI examination is performed to confirm the diagnosis of TAO | Device | Grave's disease with TAO, Grave's disease without TAO |
| Collection of life style dataCollection of life style data using quality of life questionnaire | Other | Grave's disease with TAO, Grave's disease without TAO |
Primary outcome
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.
1 secondary outcome
Cellular biomarkers for risk of TAO
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Derived from this study: PubMed 39365735Liu Z, Ke SR, Shi ZX, Zhou M, Sun L, Sun QH, Xiao B, Wang DL, Huang YJ, Lin JS, Wang HS, Zhang QK, Pan CN, Liang XW, Chen RX, Mao Z, Lin XC. Dynamic transition of Tregs to cytotoxic phenotype amid systemic inflammation in Graves' ophthalmopathy. JCI Insight. 2024 Nov 22;9(22):e181488. doi: 10.1172/jci.insight.181488.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingfeng Zheng (+8613922286455, zhyfeng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic risk factors of TAO predisposition (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.