Development of a Non-Invasive Prognostic Test for Graves... | NCT07472062

Studies
Development of a Non-Invasive Prognostic Test for Graves Orbitopathy

NCT07472062

Sponsor

University Hospital, Ghent

Status

Active, not recruiting

Last Update Posted

Mar 16, 2026Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Graves Orbitopathy
Hyperthyroidism

Interventions

Schirmer's test

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 13, 2023Actual

Primary Completion Date

Jun 25, 2024Actual

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 5, 2026

First Submission Date that Met QC Criteria

Mar 11, 2026

First Posted Date

Mar 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Schirmer's test	Other	Collection of tears with Schirmer's test	Graves' Orbitopathy Healthy controls Hyperthyroidism

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

<18 y/o

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital		Ghent		9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D049970	Graves Ophthalmopathy
D006980	Hyperthyroidism

Ancestor Terms

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D006111	Graves Disease
D005094	Exophthalmos

Browse Leaves

Not provided

Browse Branches

Not provided