Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
NCT Number: NCT07716579
This prospective single-group clinical study evaluates late endocrine and metabolic consequences in survivors of primary brain tumors treated during childhood in Slovenia.
Participants were treated for a primary brain tumor between 2008 and 2018 while aged 0 to 18 years and survived for at least 5 years after diagnosis. They undergo a standardized multidisciplinary assessment during follow-up. The assessment includes review of medical history and previous cancer treatment, anthropometric measurements, blood pressure measurement, clinical endocrine evaluation, and laboratory assessment of endocrine and metabolic markers. Available results of bone mineral density and vascular assessments are also reviewed, and additional clinically indicated assessments may be performed as part of routine follow-up.
The study aims to determine the frequency and severity of endocrine and metabolic late effects and to examine their association with tumor type and location, treatment characteristics, and physical functioning. The findings may support earlier identification of survivors at increased risk and improve individualized long-term follow-up and treatment.
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Notify Me5 year–35 year
All sexes
Interventional
Not applicable
Ljubljana, 1000, Slovenia
Survival after primary brain tumors diagnosed in childhood has improved substantially. However, survivors may develop long-term endocrine, metabolic, neurological, psychological, and cardiovascular complications. These late effects may appear several years after completion of treatment and may negatively affect health, quality of life, and life expectancy.
This prospective single-group study includes individuals who were treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years and who survived for at least 5 years after diagnosis.
Participants undergo a standardized multidisciplinary late-effects assessment during follow-up by oncology, neurology, and endocrinology specialists. Information on tumor type and location, age at diagnosis, treatment modalities, date of treatment completion, current therapy, and relevant late effects is collected from medical records and clinical evaluation.
The assessment includes body weight, height, waist and hip circumference, arm span, sitting height, repeated blood pressure measurements, and clinical assessment of pubertal development when applicable. Endocrine and metabolic laboratory parameters may include growth-related hormones, thyroid hormones, gonadotropins, sex hormones, cortisol, insulin, glucose, lipid profile, liver enzymes, vitamin D, and other clinically relevant markers.
Where available or clinically indicated, the assessment also includes bone mineral density and body composition measurement by dual-energy X-ray absorptiometry, carotid intima-media thickness measurement, and evaluation of arterial stiffness by pulse wave velocity. No investigational medicinal product is administered.
The primary objective is to determine the occurrence and severity of endocrine and metabolic late effects after treatment of childhood brain tumors. Additional analyses evaluate associations between these late effects and tumor location, tumor type, treatment modality, age at diagnosis, and physical functioning.
The results are intended to support the identification of survivors at increased risk and to contribute to the development of individualized long-term monitoring, prevention, and treatment strategies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants undergo a standardized assessment to identify endocrine and metabolic late effects after childhood brain tumor treatment. The assessment includes medical history review, anthropometric measurements, repeated blood pressure measurements, clinical evaluation of pubertal and endocrine status, and laboratory evaluation of endocrine and metabolic markers. Bone mineral density, carotid intima-media thickness, and pulse wave velocity are evaluated when available or clinically indicated. No investigational medicinal product is administered.
Time frame: At completion of the multidisciplinary late-effects assessment, through December 31, 2025
The number and percentage of participants with at least one endocrine or metabolic late effect identified during the standardized multidisciplinary assessment will be reported. Late effects are determined from medical history, clinical endocrine evaluation, anthropometric measurements, blood pressure measurements, and laboratory findings, including growth-related, thyroid, gonadal, adrenal, glucose, insulin, lipid, liver, and vitamin D parameters.
Time frame: At completion of the multidisciplinary late-effects assessment, through December 31, 2025
The occurrence and severity of endocrine and metabolic late effects will be evaluated according to tumor type and location, age at diagnosis, and treatment characteristics, including surgery, chemotherapy, and radiotherapy.
Institute of Oncology Ljubljana
Other
Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
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