Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy

NCT06590220 | Recruiting

• 1 other identifier: TAO3M-2
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Found the new diagnostic markers or imaging sequences.
2. 2.Establish and validate a multimodal and multiparameter prediction model for moderate to severe TAO.

Conditions

Thyroid Associated Ophthalmopathy

Outcome Measures

Primary Outcomes (4)

• Percentage of participants with overall response

  1 week after the end of treatment

• Percentage of participants with overall response

  24 weeks after the end of treatment

• Percentage of participants with overall response

  52 weeks after the end of treatment

• Percentage of participants with overall response

  104 weeks after the end of treatment

Secondary Outcomes (6)

• 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

Other Outcomes (4)

• change of extraocular muscle volume and orbital fat volume by MRI

  104 weeks after the end of treatment

• Change of Serum T-cell subgroup

  1 week after the end of treatment

• Change of Serum T-cell subgroup

  104 weeks after the end of treatment

Study Arms (1)

TAO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe active TAO patients who receive medical treatment and assessment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Tuo Dr. Li, Vice Professor

CONTACT

+86-13918507887; dr.lituo@smmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): September 6, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)