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

NCT ID: NCT03498417

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-20

Study Completion Date

2018-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Graves Ophthalmopathy Graves Disease Autoimmune Thyroiditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Graves' diseases

Patients with Graves' disease. No interventions foreseen

Serum antibodies against the IGF-1R

Intervention Type DIAGNOSTIC_TEST

Measurement of antibodies against the IGF-1R in serum samples by ELISA

Autoimmune thyroiditis

Patients with autoimmune thyroiditis. No interventions foreseen

Serum antibodies against the IGF-1R

Intervention Type DIAGNOSTIC_TEST

Measurement of antibodies against the IGF-1R in serum samples by ELISA

Healthy Subjects

Normal healthy subjects. No interventions foreseen

Serum antibodies against the IGF-1R

Intervention Type DIAGNOSTIC_TEST

Measurement of antibodies against the IGF-1R in serum samples by ELISA

Interventions

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Serum antibodies against the IGF-1R

Measurement of antibodies against the IGF-1R in serum samples by ELISA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Marinò Michele

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele Marinò, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

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Endocrinology Unit I, University of Pisa

Pisa, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IGF1-R-Abs

Identifier Type: -

Identifier Source: org_study_id

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