Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy

NCT ID: NCT06590220

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-09

Study Completion Date

2028-09-06

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Associated Ophthalmopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TAO

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tuo Li, MD

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tuo Dr. Li, Vice Professor

Role: CONTACT

+86-13918507887

Facility Contacts

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Tuo Dr. Li, Vice Professor

Role: primary

+86-13918507887

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 34252869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34007271 (View on PubMed)

Other Identifiers

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TAO3M-2

Identifier Type: -

Identifier Source: org_study_id

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