Graves OrbitopathyGoProNCT07472062
Development of a Non-Invasive Prognostic Test for Graves Orbitopathy
A study testing Schirmer's test in people with Graves Orbitopathy and Hyperthyroidism, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Graves Orbitopathy, Hyperthyroidism
- What is being tested?
- Schirmer's test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 13 May 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy control OR diagnosis of hyperthyroidism OR diagnosis of Graves' Orbitopathy
Who cannot join
- <18 y/o
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Graves Orbitopathy, Hyperthyroidism
- Being tested
- Schirmer's test
- Medical subject headings
- Graves Ophthalmopathy, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schirmer's testOther
Collection of tears with Schirmer's test
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Other | Schirmer's test Receives: Other: Schirmer's test |
| Hyperthyroidism | Other | Schirmer's test Receives: Other: Schirmer's test |
| Graves' Orbitopathy | Other | Schirmer's test Receives: Other: Schirmer's test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start13 May 2023
- Primary completion25 Jun 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves OrbitopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472062
- Sponsor's protocol ID
- BC-09628
- Acronym
- GoPro
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Non-Invasive Prognostic Test for Graves Orbitopathy
- ClinicalTrials.gov ID
- NCT07472062
- Acronym / sponsor ID
- GoPro / BC-09628
- Conditions
- Graves Orbitopathy, Hyperthyroidism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 13 May 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Other | Other: Schirmer's testSchirmer's test |
| Hyperthyroidism | Other | Other: Schirmer's testSchirmer's test |
| Graves' Orbitopathy | Other | Other: Schirmer's testSchirmer's test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy control OR diagnosis of hyperthyroidism OR diagnosis of Graves' Orbitopathy
Key exclusion criteria (1 listed)
- <18 y/o
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schirmer's testCollection of tears with Schirmer's test | Other | Graves' Orbitopathy, Healthy controls, Hyperthyroidism |
Primary outcome
Biomarkers found in tears collected at Baseline
Time frame: Baseline
During a one-day study visit (Baseline visit), tears will be collected from all study participants via a Schirmer's test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Graves Orbitopathy
Active, not recruitingPhase 4
Hydroxychloroquine in Mild Graves' Orbitopathy
Graves Ophthalmopathy
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
Graves Disease, Graves Disease (Basedow's Disease)
RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Thyroid Eye Disease, TED, Graves Orbitopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schirmer's test in people with Graves Orbitopathy and Hyperthyroidism, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers found in tears collected at Baseline (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.