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.
Study Type
OBSERVATIONAL
Enrollment
150
Analysis of blood specimens and neck ultrasonography
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, Italy
RECRUITINGAzienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine, Italy
ACTIVE_NOT_RECRUITINGPrevalence of pre-SD in pediatric subjects with AT
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
Time frame: At the enrolment (T0)
Prevalence of pre-SD in pediatric subjects with AT
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
Time frame: 12 months after the enrolment (T12)
Prevalence of pre-SD in pediatric subjects with AT
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
Time frame: 24 months after the enrolment (T24)
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