Graves OphthalmopathyIGF1RAbsGONCT03498417
Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy
An observational study of Graves Ophthalmopathy and Graves Disease, run by University of Pisa at 1 site in Italy.
Trial summary
The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Graves Ophthalmopathy, Graves Disease, Autoimmune Thyroiditis
- What is being tested?
- Serum antibodies against the IGF-1R
- How many people
- 135 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2018to 20 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Patients with Graves' disease, with or without GO. The presence of GO will be established in any patient who had at least one of the following eye features: a) exophthalmometry ≥17 mm in women and ≥19 mm in men, based on measurements conducted for the normal population; b) eyelid aperture ≥9 mm; c) clinical activity score ≥1/7; iv) presence of diplopia; v) presence of corneal alterations; vi) presence of GO-related alterations of the fundi; and vii) reduction in visual acuity that could be attributed to GO. 2. Patients with autoimmune thyroiditis 3. healthy subjects
Who may be able to join
- for Graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the TSH-R;
- for autoimmune thyroiditis: the presence of at least two of the following: a) primary hypothyroidism; b) detectable serum autoantibodies against thyroglobulin or thyroperoxidase ; c) a hypoechoic pattern of the thyroid by ultrasound examination.
- for healthy subjects: absence of any clinical, biochemical or instrumental evidence of thyroid diseases.
- For all subjects: Informed consent
Who cannot join
- 1) lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Antibodies Against the Insulin-like Growth Factor-1 Receptor (IGF-1R) in Graves' Disease and Graves' Orbitopathy
The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.
- Being tested
- Serum antibodies against the IGF-1R
- Medical subject headings
- Graves Ophthalmopathy, Graves Disease, Thyroiditis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum antibodies against the IGF-1RDiagnostic test
Measurement of antibodies against the IGF-1R in serum samples by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Graves' diseases | Patients with Graves' disease. No interventions foreseen Receives: Diagnostic Test: Serum antibodies against the IGF-1R | |
| Autoimmune thyroiditis | Patients with autoimmune thyroiditis. No interventions foreseen Receives: Diagnostic Test: Serum antibodies against the IGF-1R | |
| Healthy Subjects | Normal healthy subjects. No interventions foreseen Receives: Diagnostic Test: Serum antibodies against the IGF-1R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of serum IGF-1R-Abs above the upper normal levels
Percent prevalence of serum IGF-1R-Abs above the upper normal levels in patients with GO, compared with healthy subjects, patients with Graves' disease without a clinically relevant GO, and patients with autoimmune thyroiditis.
Measured: Baseline
Secondary outcomes (5)
Serum concentrations of IGF-1R-Abs
Comparison of the serum concentrations of IGF-1R-Abs in patients with GO, compared with healthy subjects, patients with Graves' disease without GO, and patients with autoimmune thyroiditis;
Measured: Baseline
Relationship between serum IGF-1R-Abs and the activity of GO
Relationship between serum IGF-1R-Abs (both levels and prevalence), with the the activity GO, namely the clinical activity score, including 7 items (spontaneous orbital pain, gaze provoked pain, palpebral redness, palpebral oedema, conjuctival redness, caruncle edema, chemosis) resulting in a score from 1 to 7
Measured: Baseline
Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies
The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyrotropic hormone-receptor serum autoantibodies
Measured: Baseline
Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies
The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroperoxidase serum autoantibodies
Measured: Baseline
Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies
The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroglobulin serum autoantibodies
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start20 Jun 2018
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marinò Michele, University of Pisa
- Investigators
- Michele Marinò, MD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498417
- Sponsor's protocol ID
- IGF1-R-Abs
- Acronym
- IGF1RAbsGO
- Status last verified
- Jul 2018
- First submitted
- 30 Mar 2018
- Last updated
- 30 Jul 2018
- 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 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Antibodies Against the Insulin-like Growth Factor-1 Receptor (IGF-1R) in Graves' Disease and Graves' Orbitopathy
- ClinicalTrials.gov ID
- NCT03498417
- Acronym / sponsor ID
- IGF1RAbsGO / IGF1-R-Abs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 13 Apr 2018 (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 study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Graves' diseases | – | Diagnostic Test: Serum antibodies against the IGF-1RPatients with Graves' disease. No interventions foreseen |
| Autoimmune thyroiditis | – | Diagnostic Test: Serum antibodies against the IGF-1RPatients with autoimmune thyroiditis. No interventions foreseen |
| Healthy Subjects | – | Diagnostic Test: Serum antibodies against the IGF-1RNormal healthy subjects. No interventions foreseen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with Graves' disease, with or without GO. The presence of GO will be established in any patient who had at least one of the following eye features: a) exophthalmometry ≥17 mm in women and ≥19 mm in men, based on measurements conducted for the normal population; b) eyelid aperture ≥9 mm; c) clinical activity score ≥1/7; iv) presence of diplopia; v) presence of corneal alterations; vi) presence of GO-related alterations of the fundi; and vii) reduction in visual acuity that could be attributed to GO. 2. Patients with autoimmune thyroiditis 3. healthy subjects
Key inclusion criteria (4 listed)
- for Graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the TSH-R;
- for autoimmune thyroiditis: the presence of at least two of the following: a) primary hypothyroidism; b) detectable serum autoantibodies against thyroglobulin or thyroperoxidase ; c) a hypoechoic pattern of the thyroid by ultrasound examination.
- for healthy subjects: absence of any clinical, biochemical or instrumental evidence of thyroid diseases.
- For all subjects: Informed consent
Key exclusion criteria (1 listed)
- 1) lack of informed consent
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 |
|---|---|---|
| Serum antibodies against the IGF-1RMeasurement of antibodies against the IGF-1R in serum samples by ELISA | Diagnostic test | Autoimmune thyroiditis, Graves' diseases, Healthy Subjects |
Primary outcome
Frequency of serum IGF-1R-Abs above the upper normal levels
Time frame: Baseline
Percent prevalence of serum IGF-1R-Abs above the upper normal levels in patients with GO, compared with healthy subjects, patients with Graves' disease without a clinically relevant GO, and patients with autoimmune thyroiditis.
5 secondary outcomes
Serum concentrations of IGF-1R-Abs
Time frame: Baseline
Relationship between serum IGF-1R-Abs and the activity of GO
Time frame: Baseline
Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies
Time frame: Baseline
Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies
Time frame: Baseline
Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Michele Marinò, MD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Ophthalmopathy and Graves Disease, run by University of Pisa at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 30 Jul 2018. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of serum IGF-1R-Abs above the upper normal levels (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 30 Jul 2018.