NCT06590220招募中不适用
Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of participants with overall response
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of participants with overall response
时间窗: 104 weeks after the end of treatment
次要结局
- Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)(1 week after the end of treatment)
- Change of Serum Lipids parameters from baseline(104 weeks after the end of treatment)
- Change of Serum T3、T4 level from baseline(104 weeks after the end of treatment)
- Change of Serum TSH level from baseline(104 weeks after the end of treatment)
- Change of Serum FT3、FT4 level from baseline(104 weeks after the end of treatment)
- Change of Serum TRAb from baseline(104 weeks after the end of treatment)
研究者
Tuo Li, MD
Deputy Director
Shanghai Changzheng Hospital
研究点 (1)
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