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

NCT ID: NCT06324578

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sjögren Autoimmune Thyroid Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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subjects with AT

AT Testing

Intervention Type DIAGNOSTIC_TEST

Analysis of blood specimens and neck ultrasonography

Interventions

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AT Testing

Analysis of blood specimens and neck ultrasonography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Trieste, , Italy

Site Status RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

Udine, , Italy

Site Status ACTIVE_NOT_RECRUITING

Countries

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Italy

Central Contacts

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Alberto Tommasini, MD PhD Prof

Role: CONTACT

[email protected]
+39.040.3785.422

Barbara Bonifacio

Role: CONTACT

[email protected]
+39.0403785.472

Facility Contacts

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Alberto Tommasini, MD PhD Prof

Role: primary

[email protected]
+39.040.785.422

Barbara Bonifacio

Role: backup

[email protected]
+39.040.3785.422

Other Identifiers

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RC 25/2023

Identifier Type: -

Identifier Source: org_study_id

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