NCT07472062

Brief Summary

The aim of this research project is to develop a non-invasive, simple, robust, and sensitive prognostic test that can identify hyperthyroidism patients who are at risk of developing Graves' Orbitopathy. This phase of the study is a research phase in which we analyze blood samples and tear fluid using standard laboratory equipment and software. The aim is to identify biomarkers that can detect patients at risk of developing Graves' Orbitopathy. Offering more personalized advice, treatment, and follow-up could potentially prevent the clinical consequences or limit their severity.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
May 2023Dec 2026

Study Start

First participant enrolled

May 13, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 5, 2026

Last Update Submit

March 11, 2026

Conditions

Graves OrbitopathyHyperthyroidism

Outcome Measures

Primary Outcomes (1)

  • Biomarkers found in tears collected at Baseline

    During a one-day study visit (Baseline visit), tears will be collected from all study participants via a Schirmer's test.

    Baseline

Study Arms (3)

Healthy controls

OTHER

Schirmer's test

Other: Schirmer's test

Hyperthyroidism

OTHER

Schirmer's test

Other: Schirmer's test

Graves' Orbitopathy

OTHER

Schirmer's test

Other: Schirmer's test

Interventions

Schirmer's testOTHER

Collection of tears with Schirmer's test

Graves' OrbitopathyHealthy controlsHyperthyroidism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy control OR diagnosis of hyperthyroidism OR diagnosis of Graves' Orbitopathy

You may not qualify if:

  • \<18 y/o

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Graves OphthalmopathyHyperthyroidism

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 16, 2026

Study Start

May 13, 2023

Primary Completion

June 25, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)