Clinical trial NCT06590220: Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy
Official title: Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thyroid Associated Ophthalmopathy
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to severe active TAO patients who receive medical treatment and assessment

Brief 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. 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.


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 \&gt;1 g of methylprednisolone for the treatment of TAO.
* Any major illness/condition or evidence of an unstable clinical condition that, in the investigator\&#39;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\&#39;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

Primary outcomes:
measure: Percentage of participants with overall response
timeFrame: 1 week after the end of treatment
measure: Percentage of participants with overall response
timeFrame: 24 weeks after the end of treatment
measure: Percentage of participants with overall response
timeFrame: 52 weeks after the end of treatment
measure: Percentage of participants with overall response
timeFrame: 104 weeks after the end of treatment
Secondary outcomes:
measure: Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
timeFrame: 1 week after the end of treatment
measure: Change of Serum Lipids parameters from baseline
timeFrame: 104 weeks after the end of treatment
measure: Change of Serum T3、T4 level from baseline
timeFrame: 104 weeks after the end of treatment
measure: Change of Serum TSH level from baseline
timeFrame: 104 weeks after the end of treatment
measure: Change of Serum FT3、FT4 level from baseline
timeFrame: 104 weeks after the end of treatment
measure: Change of Serum TRAb from baseline
timeFrame: 104 weeks after the end of treatment
Other outcomes:
measure: change of extraocular muscle volume and orbital fat volume by MRI
timeFrame: 104 weeks after the end of treatment
measure: Change of Serum T-cell subgroup
timeFrame: 1 week after the end of treatment
measure: Change of Serum T-cell subgroup
timeFrame: 104 weeks after the end of treatment
measure: change of extraocular muscle volume and orbital fat volume by MRI
timeFrame: 4 weeks after the end of treatment
Locations:
Study officials:
References:
citation: 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.
citation: 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.