Thyroid Associated OphthalmopathyNCT06590220
Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy
An observational study of Thyroid Associated Ophthalmopathy, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Associated Ophthalmopathy
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to 6 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Moderate to severe active TAO patients who receive medical treatment and assessment
Who may be able to join
- According to the Bartley criteria，diagnosed TAO at our hospital after 2024/8/31
- Moderate to severe patients defined by EUGOGO
- CAS ≥3 (on the 7-item scale) for the study eye
Who cannot join
- Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
- History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \>1 g of methylprednisolone for the treatment of TAO.
- Any major illness/condition or evidence of an unstable clinical condition that, in the investigator\'s judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
- Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant\'s participation in the study
- Pregnant or lactating
- Any other condition that,would impair the ability of the participant to undergo orbital MRI
- Incomplete information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Tuo Dr. Li, Vice Professor, +86-13918507887, zoe_leeto@hotmail.com
young.stone@163.com
About this study
Official title: Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy
Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.
The aim of this clinical study is to:
- Found the new diagnostic markers or imaging sequences.
- Establish and validate a multimodal and multiparameter prediction model for moderate to severe TAO.
- Conditions
- Thyroid Associated Ophthalmopathy
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAO | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with overall response
Measured: 1 week after the end of treatment
Percentage of participants with overall response
Measured: 24 weeks after the end of treatment
Percentage of participants with overall response
Measured: 52 weeks after the end of treatment
Percentage of participants with overall response
Measured: 104 weeks after the end of treatment
Secondary outcomes (6)
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Safety and Tolerability
Measured: 1 week after the end of treatment
Change of Serum Lipids parameters from baseline
including TG（mmol/L）、TC（mmol/L）、HDL（mmol/L）、LDL（mmol/L）
Measured: 104 weeks after the end of treatment
Change of Serum T3、T4 level from baseline
including T3（nmol/L）、T4（nmol/L）
Measured: 104 weeks after the end of treatment
Change of Serum TSH level from baseline
including TSH（mIU/L）
Measured: 104 weeks after the end of treatment
Change of Serum FT3、FT4 level from baseline
including FT3（pmol/L）、FT4（pmol/L）
Measured: 104 weeks after the end of treatment
Change of Serum TRAb from baseline
including TRAb（IU/l）
Measured: 104 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Oct 2024
- Primary completion6 Sep 2026 (estimated)
- Study completion6 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Shanghai Changzheng HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuo Li, MD, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590220
- Sponsor's protocol ID
- TAO3M-2
- Status last verified
- Jun 2025
- First submitted
- 29 Aug 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhai L, Luo B, Wu H, Wang Q, Yuan G, Liu P, Ma Y, Zhao Y, Zhang J. Prediction of treatment response to intravenous glucocorticoid in patients with thyroid-associated ophthalmopathy using T2 mapping and T2 IDEAL. Eur J Radiol. 2021 Sep;142:109839. doi: 10.1016/j.ejrad.2021.109839. Epub 2021 Jul 3.
PubMed 34252869Cevik Y, Taylan Sekeroglu H, Ozgen B, Erkan Turan K, Sanac AS. Clinical and Radiological Findings in Patients with Newly Diagnosed Graves' Ophthalmopathy. Int J Endocrinol. 2021 Apr 30;2021:5513008. doi: 10.1155/2021/5513008. eCollection 2021.
PubMed 34007271
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy
- ClinicalTrials.gov ID
- NCT06590220
- Acronym / sponsor ID
- TAO3M-2
- Conditions
- Thyroid Associated Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 6 Sep 2026 (estimated)
- Study completion
- 6 Sep 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.
The aim of this clinical study is to:
- Found the new diagnostic markers or imaging sequences.
- Establish and validate a multimodal and multiparameter prediction model for moderate to severe TAO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAO | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to severe active TAO patients who receive medical treatment and assessment
Key inclusion criteria (3 listed)
- According to the Bartley criteria，diagnosed TAO at our hospital after 2024/8/31
- Moderate to severe patients defined by EUGOGO
- CAS ≥3 (on the 7-item scale) for the study eye
Key exclusion criteria (7 listed)
- Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
- History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \>1 g of methylprednisolone for the treatment of TAO.
- Any major illness/condition or evidence of an unstable clinical condition that, in the investigator\'s judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
- Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant\'s participation in the study
- Pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants with overall response
Time frame: 1 week after the end of treatment
Percentage of participants with overall response
Time frame: 24 weeks after the end of treatment
Percentage of participants with overall response
Time frame: 52 weeks after the end of treatment
Percentage of participants with overall response
Time frame: 104 weeks after the end of treatment
6 secondary outcomes
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Time frame: 1 week after the end of treatment
Change of Serum Lipids parameters from baseline
Time frame: 104 weeks after the end of treatment
Change of Serum T3、T4 level from baseline
Time frame: 104 weeks after the end of treatment
Change of Serum TSH level from baseline
Time frame: 104 weeks after the end of treatment
Change of Serum FT3、FT4 level from baseline
Time frame: 104 weeks after the end of treatment
Change of Serum TRAb from baseline
Time frame: 104 weeks after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 34252869Zhai L, Luo B, Wu H, Wang Q, Yuan G, Liu P, Ma Y, Zhao Y, Zhang J. Prediction of treatment response to intravenous glucocorticoid in patients with thyroid-associated ophthalmopathy using T2 mapping and T2 IDEAL. Eur J Radiol. 2021 Sep;142:109839. doi: 10.1016/j.ejrad.2021.109839. Epub 2021 Jul 3.
- Background: PubMed 34007271Cevik Y, Taylan Sekeroglu H, Ozgen B, Erkan Turan K, Sanac AS. Clinical and Radiological Findings in Patients with Newly Diagnosed Graves' Ophthalmopathy. Int J Endocrinol. 2021 Apr 30;2021:5513008. doi: 10.1155/2021/5513008. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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 Shanghai Changzheng Hospital at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuo Dr. Li, Vice Professor (+86-13918507887, dr.lituo@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with overall response (time frame: 1 week after the end of treatment). The study lists 4 primary outcomes in all. 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 NCT06590220, which also lists 2 linked publications.
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 24 Jun 2025.