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By invitation only NCT07544290

Autoimmune Hyperthyroidism in Prepubertal Children

Conditions: Autoimmune Hyperthyroidism Children

Sponsor: IRCCS Ospedale San Raffaele

trial.available_in: БГ
Overview
The investigators propose a multicenter retrospective study to assess clinical, biochemical, and auxological characteristics at diagnosis and during follow-up in a cohort of Caucasian pediatric patients diagnosed with autoimmune hyperthyroidism before puberty. These prepubertal patients will be compared with a control group of post-pubertal patients with Graves' disease. This study aims to enhance the understanding of autoimmune hyperthyroidism in prepubertal patients by providing a detailed evaluation of disease onset, therapeutic response, and growth-related outcomes. The inclusion of a carefully matched post-pubertal control group will allow for robust comparative analysis and identification of age-dependent clinical patterns and prognostic indicators, ultimately supporting more tailored and effective management strategies in pediatric populations at this particular age.
Description
There are only few studies in literature focusing on the analysis of cohorts of patients with autoimmune hyperthyroidism with onset exclusively in early childhood. The investigators therefore propose this study with the aim of retrospectively assessing characteristics at onset and during follow-up in a cohort of Caucasian hyperthyroid subjects diagnosed with the disease before puberty. OBJECTIVES AND ENDPOINTS * Primary Objective To evaluate the clinical and biochemical features at the onset of autoimmune hyperthyroidism in patients diagnosed in prepubertal age Secondary Objectives 1. To evaluate of biochemical parameters during medical therapy 2. To evaluate of auxological parameters at diagnosis and during follow-up 3. To compare the previous data with the clinical and biochemical features at diagnosis and during the follow-up in patients diagnosed with Graves during the pubertal age (\> Tanner 2) Inclusion Criteria 1. Subjects with autoimmune hyperthyroidism 2. Prepubertal stage (Tanner 1) at diagnosis Exclusion Criteria 3. Subjects with hyperthyroidism not of autoimmune aetiology 4. Pubertal stage (\>Tanner 2) at diagnosis Sample size: * 50 hyperthyroid subjects diagnosed with the disease before puberty * 50 hyperthyroid subjects diagnosed with the disease during and post puberty The data will then be analyzed using PRISM software. The principal investigator will verify the completeness, correctness, consistency and congruence of the reported data.
Who can participate
Inclusion Criteria: -Subjects with autoimmune hyperthyroidism Exclusion Criteria: * Subjects with hyperthyroidism not of autoimmune aetiology
Interventions
restrospective observational study
OTHER
Locations 1
Italy (1)
IRCCS Ospedale San Raffaele
Milan , Italy
Technical details
Status
By invitation only
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
01.01.2026
Completion date
01.12.2026
Registry ID
NCT07544290
Source
clinicaltrials.gov
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