Investigating the link between autoimmune thyroiditis and Sjögren Disease in children
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.
This study is trying to see if children with autoimmune thyroiditis also have early signs of Sjögren Disease that might not show obvious symptoms yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 2 sites (Trieste and 1 other locations) |
| Trial ID | NCT06324578 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the prevalence of pre-clinical Sjögren Disease (SD) in children and adolescents diagnosed with autoimmune thyroiditis (AT). The hypothesis suggests that SD may manifest subclinically in younger populations, potentially years before clinical symptoms appear. By utilizing routine blood tests and neck ultrasounds, the study seeks to identify early signs of SD in this high-risk group. The findings could enhance understanding of the relationship between these autoimmune conditions and improve early detection strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 0-17 years with a diagnosis of autoimmune thyroiditis.
Not a fit: Patients without autoimmune thyroiditis or those with active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and management of Sjögren Disease in young patients with autoimmune thyroiditis.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated a connection between autoimmune conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trieste and 1 other locations
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) — Udine, Italy (Active_not_recruiting)
Study contacts
- Study coordinator: Alberto Tommasini, MD PhD Prof
- Email: alberto.tommasini@burlo.trieste.it
- Phone: +39.040.3785.422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.