Multiparametric prediction models for moderate to severe thyroid-associated eye disease
Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy
This project will try to build and test combined imaging and lab-marker models to predict outcomes in adults with moderate to severe thyroid-associated ophthalmopathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06590220 on ClinicalTrials.gov |
What this trial studies
Researchers at Shanghai Changzheng Hospital will enroll adults diagnosed with moderate to severe TAO (Bartley and EUGOGO definitions, CAS ≥3) and collect clinical data, multimodal imaging, and laboratory markers. The observational protocol will use these multimodal inputs to train multiparametric statistical and machine-learning models aimed at predicting disease course and treatment needs. Models will be developed on one set of participants and validated on another to measure predictive accuracy and generalizability. No investigational treatments are given as part of participation; involvement focuses on data and imaging collection.
Who should consider this trial
Good fit: Adults with moderate to severe TAO meeting Bartley and EUGOGO criteria with CAS ≥3 in the study eye, who have not received high cumulative systemic steroids for TAO and can attend Shanghai Changzheng Hospital, are ideal candidates.
Not a fit: Patients needing immediate sight‑saving interventions, those with prior high cumulative steroid treatment for TAO, or those with major unstable illnesses are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, the prediction models could help clinicians choose the right treatments earlier and reduce the risk of vision‑threatening complications.
How similar studies have performed: Prior research has found individual imaging features and biomarkers linked to TAO activity, but comprehensive multiparametric prediction models are relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Tuo Dr. Li, Vice Professor
- Email: dr.lituo@smmu.edu.cn
- Phone: +86-13918507887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.