NCT06590220 Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy
| NCT ID | NCT06590220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Changzheng Hospital |
| Condition | Thyroid Associated Ophthalmopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-09 |
| Primary Completion | 2026-09-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-10-09 with a primary completion date of 2026-09-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \>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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06590220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Thyroid Associated Ophthalmopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06590220 currently recruiting?
Yes, NCT06590220 is actively recruiting participants. Contact the research team at dr.lituo@smmu.edu.cn for enrollment information.
Where is the NCT06590220 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06590220 clinical trial?
NCT06590220 is sponsored by Shanghai Changzheng Hospital. The trial plans to enroll 150 participants.