Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Thyroid Associated Ophthalmopathy. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy
Обзор
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.
Первичные конечные точки
- Percentage of participants with overall response [Срок оценки: 1 week after the end of treatment]
- Percentage of participants with overall response [Срок оценки: 24 weeks after the end of treatment]
- Percentage of participants with overall response [Срок оценки: 52 weeks after the end of treatment]
- Percentage of participants with overall response [Срок оценки: 104 weeks after the end of treatment]
Вторичные конечные точки (6)
- Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) [Срок оценки: 1 week after the end of treatment]
- Change of Serum Lipids parameters from baseline [Срок оценки: 104 weeks after the end of treatment]
- Change of Serum T3、T4 level from baseline [Срок оценки: 104 weeks after the end of treatment]
- Change of Serum TSH level from baseline [Срок оценки: 104 weeks after the end of treatment]
- Change of Serum FT3、FT4 level from baseline [Срок оценки: 104 weeks after the end of treatment]
- Change of Serum TRAb from baseline [Срок оценки: 104 weeks after the end of treatment]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Shanghai Changzheng Hospital — Шанхай
Публикации
- 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
Идентификаторы
NCT: NCT06590220 · TAO3M-2