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Development of a risk prediction model for Graves' orbitopathy using systematic ophthalmological data and inflammatory metabolic biomarkers in patients with newly diagnosed Graves' disease

NCT ID NCT07812194

NEW Sponsor: University of Copenhagen Source: ClinicalTrials.gov ↗

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Cancelled before anyone took part.

Expanded access (not trials)

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When the status isn't known

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First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

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-fluid samples, and a small swab sample from the ocular surface The study will also include healthy volunteers and participants with moderate-to-severe TED. Participants in these comparison groups will attend one study visit. Researchers will compare findings across the groups to better understand the early clinical and biological changes associated with thyroid eye disease. The long-term aim is to improve the early detection and follow-up of people with GD who may be at increased risk of developing TED.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 430 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Newly diagnosed GD cohort: Potential participants will be identified through approved recruitment reports based on EPIC/Sundhedsplatformen and laboratory data. Reports will identify adults referred to endocrinology outpatient clinics in the Capital Region of Denmark with first-time TRAb \>1.5 IU/L and TSH \<0.01 mU/L, and no previous TRAb \>1.5 IU/L. Participants may also be recruited through public announcements. Moderate-to-severe TED group: Participants will be identified among patients followed at the Endocrinology Outpatient Clinic, Herlev Hospital, and approached during a scheduled visit. Healthy control group: Participants will be recruited through staff advertisements at Herlev and Gentofte Hospital and public announcements.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves disease Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graves' disease Graves' orbitopathy Thyroid eye disease, ted

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Medical Diseases, Endocrinology Unit, Herlev-Gentofte Hospital

    Herlev, 2730, Denmark

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Other studies related to the condition(s) this trial covers.