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

Recruiting

• Conditions: Sjögren; Autoimmune Thyroid Disease
• Interventions: Diagnostic Test: AT Testing

• Registration Number: NCT06324578
• Lead Sponsor: IRCCS Burlo Garofolo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-22
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Subjects between 0-17 years with autoimmune thyroiditis
• Subjects between 0-17 years with previous diagnosis of SD or pre-SD

Exclusion Criteria

• No informed consent from the patient's guardians
• Active or recent infection within one week

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
subjects with AT	AT Testing	-

Primary Outcome Measures

Name	Time	Method
Prevalence of pre-SD in pediatric subjects with AT	24 months after the enrolment (T24)	Pre-SD will be considered in cases with positive Anti-Sjögren's Syndrome A/Anti-Sjögren's Syndrome B antibodies and a positive Outcome Measures in Rheumatology (OMERACT) score at SGUS and/or a "Focus score" ≥1 at labial salivary gland (LSG) or parotid gland biopsy.; Pre-SD definition meets the American college of rheumatology (ACR)/European league against rheumatism (EULAR) classification criteria for Sjogren Disease if symptoms suspicious of SD are present.; Non-SD Sialadenitis is defined by a positive SGUS with negative SD related antibodies

Trial Locations

Locations (2)

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC); 🇮🇹 Udine, Italy

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"; 🇮🇹 Trieste, Italy