RecruitingNCT06324578

Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease

A Cross-sectional Observational Study, Based on Immunological and Ultrasonographic Evaluations, to Define the Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis.


Sponsor

IRCCS Burlo Garofolo

Enrollment

150 participants

Start Date

Sep 25, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine.


Eligibility

Min Age: 0 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how common early (pre-clinical) Sjögren's disease and other immune system disturbances are in children with autoimmune thyroid disease (a condition where the immune system attacks the thyroid gland). Sjögren's disease affects the glands that produce saliva and tears and is also an autoimmune condition. **You may be eligible if:** - You are between 0 and 17 years old - You have been diagnosed with autoimmune thyroiditis (such as Hashimoto's thyroiditis), OR - You have a previous diagnosis of Sjögren's disease or pre-clinical Sjögren's disease **You may NOT be eligible if:** - Your parent or legal guardian has not provided informed consent - You have had an active or recent infection within the past week Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAT Testing

Analysis of blood specimens and neck ultrasonography


Locations(2)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, Italy

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

Udine, Italy

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NCT06324578


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