Early risk stratification of thyroid eye disease in newly diagnosed Graves' disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational cohort study conducted in the Capital Region of Denmark. It enrolls adults with newly diagnosed Graves’ disease and follows them for about one year, collecting clinical data, eye examinations, photographs, and biological samples (blood, tears, and a small ocular surface swab). A healthy control group and a moderate-to-severe TED group are included to contextualize findings. The goal is to identify early predictors of thyroid eye disease to enable closer ophthalmologic monitoring and timely referrals. The study will analyze clinical, biochemical, tear fluid, and ocular surface microbiome biomarkers to see which factors are associated with higher TED risk.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Birte Nygaard, M.D., Ph.D. — Herlev Hospital
• Study coordinator: Birte Nygaard, M.D., Ph.D
• Email: birte.nygaard@regionh.dk
• Phone: +4538689527

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.