Evaluating thyroid function and structure in Klinefelter syndrome
Thyroid Function and Structure in Klinefelter Syndrome (THINKS)
University of Roma La Sapienza · NCT05581147
This study is testing how well the thyroid works and looks in people with Klinefelter syndrome compared to healthy individuals and those with a specific thyroid condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 1 Year to 80 Years |
| Sex | Male |
| Sponsor | University of Roma La Sapienza (other) |
| Locations | 1 site (Roma) |
| Trial ID | NCT05581147 on ClinicalTrials.gov |
What this trial studies
This longitudinal retrospective study aims to evaluate thyroid function and structure in patients with Klinefelter syndrome by comparing them to healthy controls and patients with chronic lymphocytic thyroiditis. The study will analyze peripheral hormone levels and ultrasonographic thyroid structure based on pubertal and gonadal status. Data will be collected from patients diagnosed with Klinefelter syndrome at the host institution, focusing on thyroid function tests and imaging results. The primary outcome will assess thyroid function through various hormone levels, while secondary outcomes will include detailed ultrasonographic parameters of thyroid structure.
Who should consider this trial
Good fit: Ideal candidates include males with a confirmed diagnosis of classic, non-mosaic 47,XXY Klinefelter syndrome who have available thyroid function test results.
Not a fit: Patients with other known genetic conditions, those on thyroid-affecting medications, or those with a history of thyroid surgery or therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of thyroid health in patients with Klinefelter syndrome, leading to better management and treatment strategies.
How similar studies have performed: While there may be studies on thyroid function in other conditions, this specific evaluation in Klinefelter syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a confirmed diagnosis of classic, non-mosaic 47,XXY Klinefelter syndrome based on a peripheral blood 97 karyotype analysis; * Availability of thyroid function test results (TSH, fT3, and fT4) and/or thyroid US imaging; * Availability of concurrent clinical data. Exclusion Criteria: * Presence of other known genetic conditions or chromosomal abnormalities; * Use of levothyroxine or other drugs that are either active on the hypothalamic-pituitary-thyroid (HPT) axis or that may interfere with thyroid function tests; * History of previous surgery or radiotherapy on the thyroid or pituitary glands; * Current or previous T therapy (for the pre-pubertal and pubertal groups).
Where this trial is running
Roma
- 'Sapienza' University of Rome — Roma, Italy (RECRUITING)
Study contacts
- Principal investigator: Andrea M Isidori, MD, PhD — andrea.isidori@uniroma1.it
- Study coordinator: Andrea M Isidori, MD, PhD
- Email: andrea.isidori@uniroma1.it
- Phone: 0039649970711
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.
Conditions: Klinefelter Syndrome, Thyroiditis, Autoimmune, Hypothyroidism, Klinefelter syndrome, Thyroiditis, Puberty, Prepuberty, Testosterone