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Trial record 23 of 40 for:    "Hashimoto thyroiditis" OR "Hashimoto Disease"

Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy (IGF1RAbsGO)

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ClinicalTrials.gov Identifier: NCT03498417
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Marinò Michele, University of Pisa

Brief 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.

Condition or disease Intervention/treatment
Graves Ophthalmopathy Graves Disease Autoimmune Thyroiditis Diagnostic Test: Serum antibodies against the IGF-1R

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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Serum Antibodies Against the Insulin-like Growth Factor-1 Receptor (IGF-1R) in Graves' Disease and Graves' Orbitopathy
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018


Group/Cohort Intervention/treatment
Graves' diseases
Patients with Graves' disease. No interventions foreseen
Diagnostic Test: Serum antibodies against the IGF-1R
Measurement of antibodies against the IGF-1R in serum samples by ELISA

Autoimmune thyroiditis
Patients with autoimmune thyroiditis. No interventions foreseen
Diagnostic Test: Serum antibodies against the IGF-1R
Measurement of antibodies against the IGF-1R in serum samples by ELISA

Healthy Subjects
Normal healthy subjects. No interventions foreseen
Diagnostic Test: Serum antibodies against the IGF-1R
Measurement of antibodies against the IGF-1R in serum samples by ELISA




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Serum concentrations of IGF-1R-Abs [ Time Frame: Baseline ]
    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;

  2. Relationship between serum IGF-1R-Abs and the activity of GO [ Time Frame: Baseline ]
    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

  3. Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies [ Time Frame: Baseline ]
    The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyrotropic hormone-receptor serum autoantibodies

  4. Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies [ Time Frame: Baseline ]
    The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroperoxidase serum autoantibodies

  5. Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies [ Time Frame: Baseline ]
    The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroglobulin serum autoantibodies


Biospecimen Retention:   Samples Without DNA
Serum samples


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  1. for Graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the TSH-R;
  2. 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.
  3. for healthy subjects: absence of any clinical, biochemical or instrumental evidence of thyroid diseases.

For all subjects: Informed consent

Exclusion Criteria:

1) lack of informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498417


Locations
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Italy
Endocrinology Unit I, University of Pisa
Pisa, Italy, 56124
Sponsors and Collaborators
University of Pisa
Investigators
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Principal Investigator: Michele Marinò, MD University of Pisa

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Responsible Party: Marinò Michele, Assistant Professor, University of Pisa
ClinicalTrials.gov Identifier: NCT03498417     History of Changes
Other Study ID Numbers: IGF1-R-Abs
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hashimoto Disease
Graves Disease
Graves Ophthalmopathy
Thyroiditis
Thyroiditis, Autoimmune
Eye Diseases
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Antibodies
Immunoglobulins
Autoantibodies
Mecasermin
Physiological Effects of Drugs
Immunologic Factors
Growth Substances