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

NCT06324578 | Recruiting

• 1 other identifier: RC 25/2023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Sjögren; Autoimmune Thyroid Disease

Keywords

Autoimmune Thyroiditis; Sjögren disease; Immune dysregulation disorders

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

subjects with AT

Diagnostic Test: AT Testing

Interventions

AT Testing DIAGNOSTIC_TEST

Analysis of blood specimens and neck ultrasonography

subjects with AT

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with autoimmune thyroiditis and previous diagnosis of SD or pre-SD

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (2)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

Udine, Italy

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Sjogren's Syndrome; Thyroiditis, Autoimmune

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Thyroiditis; Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Alberto Tommasini, MD PhD Prof

CONTACT

+39.040.3785.422; alberto.tommasini@burlo.trieste.it

Barbara Bonifacio

CONTACT

+39.0403785.472; barbara.bonifacio@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: September 25, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-03

Locations

IT (2)