Autoimmune Thyroid Disease, Sjögren
Conditions
Keywords
Autoimmune Thyroiditis, Sjögren disease, Immune dysregulation disorders
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.
Interventions
DIAGNOSTIC_TESTAT Testing
Analysis of blood specimens and neck ultrasonography
Sponsors
IRCCS Burlo Garofolo
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of pre-SD in pediatric subjects with AT | At the enrolment (T0) | 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 |
Countries
Italy
Contacts
Primary ContactAlberto Tommasini, MD PhD Prof
Backup ContactBarbara Bonifacio
Outcome results
None listed