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临床试验/NCT06324578
NCT06324578招募中不适用

A Cross-sectional Observational Study, Based on Immunological and Ultrasonographic Evaluations, to Define the Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis.

IRCCS Burlo Garofolo2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
Prevalence of pre-SD in pediatric subjects with AT

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Prevalence of pre-SD in pediatric subjects with AT

时间窗: 24 months after the enrolment (T24)

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

次要结局

未报告次要终点

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Sponsor

研究点 (2)

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