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

IRCCS Burlo Garofolo

Status: Enrolling

Conditions: Autoimmune Thyroid Disease; Sjögren

Treatments: Diagnostic Test: AT Testing

Study type: Observational

Funder types: Other

Identifiers

NCT06324578

RC 25/2023

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

subjects with AT

Treatment:

Diagnostic Test: AT Testing