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Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease

Recruitingn/aAges 18 Years - anyAllUniversity of Copenhagen
NCT07812194 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this observational study is to investigate why some people with newly diagnosed Graves' disease (GD) develop thyroid eye disease (TED), also known as Graves' orbitopathy, while others do not. The main questions the study aims to answer are: 1. What proportion of participants develop TED within one year of being diagnosed with GD? 2. Which early clinical signs, ophthalmological findings, blood biomarkers, tear-fluid biomarkers, or ocular surface microbiome characteristics are associated with an increased risk of developing thyroid eye disease? Participants with newly diagnosed GD will attend two study visits, one at baseline and one approximately one year later. At each visit, participants will: * Answer questions about their symptoms and quality of life * Undergo a standardized eye examination and have clinical photographs taken of their eyes * Provide blood samples, tear-

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📋 Eligibility rules (as published)
Inclusion Criteria: Newly Diagnosed Graves' Disease (GD) Cohort: * Age 18 years or older * Newly diagnosed GD * Positive TSH receptor antibodies, defined as TRAb \>1.5 IU/L * Biochemical hyperthyroidism, defined as TSH \<0.01 mIU/L * Residence in and/or clinical management within the Capital Region of Denmark, including Hvidovre Hospital, Rigshospitalet, Amager Hospital, Nordsjællands Hospital, Herlev Hospital, and Bispebjerg Hospital. * Ability to provide oral and written informed consent Healthy Control Group: * Age 18 years or older * No known history of GD * No previous positive TRAb measurement * No known thyroid dysfunction requiring antithyroid drug therapy or thyroid hormone replacement therapy * Ability to provide oral and written informed consent Moderate-to-Severe Thyroid Eye Disease (TED) Group: * Age 18 years or older * Diagnosis of moderate-to-severe TED * Followed or treated in a relevant specialized clinical setting * Ability to provide oral and written informed consent Exclusion Criteria: Newly Diagnosed GD Cohort: * Age below 18 years * Previous documented TRAb measurement \>1.5 IU/L prior to the current diagnostic episode * Inability to provide informed consent * Inability to complete the baseline assessment within the predefined study timeframe Healthy Control Group: * Age below 18 years * Known Graves' disease or previous positive TRAb measurement * Known thyroid dysfunction requiring antithyroid drug therapy or thyroid hormone replacement therapy * Inability to provide informed consent Moderate-to-Severe TED Group: * Age below 18 years * Inability to provide informed consent * Inability to complete the planned study assessment
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What it tests

  • Study-related ophthalmological assessment and biospecimen collection
  • Blood biomarkers and standardized blood samples including thyroid function status
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Where

1 site
Department of Medical Diseases, Endocrinology Unit, Herlev-Gentofte Hospital
Herlev, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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