An observational study in Autoimmune Hyperthyroidism and Children, sponsored by IRCCS Ospedale San Raffaele. Enrolling by invitation at 1 site in Italy. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by IRCCS Ospedale San Raffaele · Observational
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.
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
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:
The data will then be analyzed using PRISM software. The principal investigator will verify the completeness, correctness, consistency and congruence of the reported data.
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 56 observational studies indexed under Graves Disease.
Browse Graves Disease studies →IRCCS Ospedale San Raffaele is the lead sponsor of 36 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We enrolled all patients affected by autoimmune hyperthyroidism in prepubertal age and pubertal age to compare 2 groups
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Subjects with hyperthyroidism
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: restrospective observational study
Other: restrospective observational study
we collect clinical, hormonal and follow up data and compare data in prepubertal and pubertal patients affected by autoimmune hyperthyroidism
Number of clinical signs of hyperthyroidism at diagnosis
Total number of clinical signs (including goiter, exophthalmos, and tachycardia) present at diagnosis, recorded as a count per patient.
Time frame: Day 0 (retrospective assessment at diagnosis)
Number of clinical symptoms at diagnosis
Total number of symptoms per patient, categorized as none (0), mild (1-2), moderate (3-5), or severe (\>5).
Time frame: Day 0
Serum free triiodothyronine (FT3) levels at diagnosis
Measurement of serum FT3 (pmol/L) at diagnosis.
Time frame: Day 0
Serum free thyroxine (FT4) levels at diagnosis
Measurement of serum FT4 (pmol/L) at diagnosis.
Time frame: Day 0
Serum thyroid-stimulating hormone (TSH) levels at diagnosis
Measurement of serum TSH (mIU/L) at diagnosis.
Time frame: Day 0
Serum TSH receptor antibody (TRAb) levels at diagnosis
Measurement of TRAb levels (IU/L) at diagnosis.
Time frame: Day 0
Thyroid autoantibody positivity at diagnosis (TPOAb and TgAb)
Presence or absence of thyroid autoantibodies (TPOAb and TgAb), reported as positive/negative.
Time frame: Day 0
Duration of antithyroid drug therapy
Time in months from initiation of antithyroid drug therapy to treatment discontinuation or switch to definitive therapy, whichever occurs first.
Time frame: Baseline (treatment initiation) to treatment discontinuation (up to 24 months)
Remission rate after antithyroid drug therapy
Proportion of patients achieving sustained normalization of thyroid function (TSH, FT3, FT4) for at least 12 months after discontinuation of therapy.
Time frame: At 24 months after treatment initiation
Rate of definitive treatment (thyroidectomy or radioactive iodine therapy)
Proportion of patients requiring definitive treatment, defined as thyroidectomy or radioactive iodine therapy.
Time frame: Baseline to 24 months
Serum TSH receptor antibody (TRAb) levels at time of the definitive treatment
Measurement of serum TRAb levels (IU/L) at the time of transition to definitive therapy.
Time frame: At time of definitive treatment (up to 24 months)
Time to normalization of thyroid function
Time in weeks from initiation of antithyroid therapy to normalization of FT3, FT4, and TSH levels.
Time frame: Baseline to normalization (up to 12 months)
Aauxological parameters at diagnosis and during follow-up
delta target height
Time frame: day 0, diagnosis; at 6 months; at 12 months
Number of antithyroid drug discontinuation attempts
Number of attempts to discontinue antithyroid therapy per patient, categorized as successful or unsuccessful based on biochemical remission.
Time frame: Baseline to 24 months
Annual growth velocity during follow-up
Change in height per year (cm/year).
Time frame: Baseline to 24 months
Bone age during follow-up
Bone age assessed using Greulich and Pyle method.
Time frame: At baseline, 12 months, and 24 months
Plan to share: Undecided
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IRCCS Ospedale San Raffaele