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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06324578
Other study ID # RC 25/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 25, 2023
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source IRCCS Burlo Garofolo
Contact Alberto Tommasini, MD PhD Prof
Phone +39.040.3785.422
Email alberto.tommasini@burlo.trieste.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years to 17 Years
Eligibility 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


Intervention

Diagnostic Test:
AT Testing
Analysis of blood specimens and neck ultrasonography

Locations

Country Name City State
Italy Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" Trieste
Italy Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Udine

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
At the enrolment (T0)
Primary 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
12 months after the enrolment (T12)
Primary 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
24 months after the enrolment (T24)