Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Thyroid Associated Ophthalmopathy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy
Overview
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: 1. Found the new diagnostic markers or imaging sequences. 2. Establish and validate a multimodal and multiparameter prediction model for moderate to severe TAO.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Changzheng Hospital — Shanghai
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. PMID 34252869
- Cevik 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. PMID 34007271
Identifiers
NCT: NCT06590220 · TAO3M-2