Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Prevalence of Endocrine and Metabolic Late Complications
Overview
Brief Summary
This interventional study evaluates the late endocrine and metabolic consequences of treatment of primary brain tumors in childhood. Childhood brain tumor survivors are at increased risk of developing long-term complications such as hormonal deficiencies, obesity, impaired growth, dyslipidemia, and other metabolic disorders, which may significantly affect long-term health and quality of life.
The aim of this study is to assess the prevalence and severity of endocrine and metabolic late effects in patients treated for brain tumors during childhood in Slovenia, and to identify associations with tumor localization, treatment modality, and physical performance.
Participants undergo structured clinical follow-up examinations and targeted endocrine and metabolic assessments according to the study protocol. The results of this study may help identify individuals at increased risk and improve long-term follow-up strategies, prevention, and management of late treatment-related complications.
Detailed Description
This is a prospective interventional clinical study designed to evaluate the prevalence and severity of late endocrine and metabolic complications in survivors of primary brain tumors treated during childhood. Advances in pediatric oncology have improved survival, but many patients develop long-term health consequences that require systematic monitoring and early management.
The study includes patients who were treated for primary brain tumors during childhood and are followed at the Institute of Oncology Ljubljana. Participants undergo standardized clinical assessments as part of the study intervention, including evaluation of endocrine function, metabolic status, and physical competence. The study aims to determine the occurrence of late endocrine and metabolic disorders and to assess the relationship between these complications and clinical factors such as tumor localization, treatment modality (surgery, radiotherapy, chemotherapy), and overall functional status.
The primary objectives are:
to assess the prevalence of endocrine disorders (e.g., growth hormone deficiency, thyroid dysfunction, gonadal dysfunction, adrenal insufficiency) after childhood brain tumor treatment,
to evaluate metabolic consequences including obesity, dyslipidemia, insulin resistance, and other metabolic abnormalities,
to analyze associations between late effects and tumor localization, treatment characteristics, and physical competence of the participants.
The study is expected to provide important national data regarding late endocrine and metabolic outcomes in childhood brain tumor survivors in Slovenia and contribute to identification of patients at higher risk. The results may support development of improved follow-up protocols and preventive strategies, as well as timely referral for appropriate endocrine and metabolic treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of primary brain tumor diagnosed and treated in childhood
- •Completed treatment for primary brain tumor (surgery and/or radiotherapy and/or chemotherapy)
- •Patient is in follow-up care at the Institute of Oncology Ljubljana
- •Availability for clinical endocrine and metabolic assessment
- •Written informed consent provided by the participant or legal guardian (if applicable)
Exclusion Criteria
- •Active malignant disease requiring ongoing oncological treatment
- •Severe acute illness preventing participation in endocrine/metabolic evaluation
- •Inability to comply with study procedures or follow-up assessments
- •Refusal or inability to provide informed consent
Arms & Interventions
Late Effects Assessment Group
Participants treated for primary brain tumors in childhood undergo a structured follow-up assessment to evaluate late endocrine and metabolic complications. The study includes clinical examination, anthropometric measurements, laboratory endocrine and metabolic testing, and evaluation of physical competence. Outcomes are analyzed in relation to tumor location and previous treatment modalities.
Intervention: Endocrine and Metabolic Late Effects Assessment (Diagnostic Test)
Outcomes
Primary Outcomes
Prevalence of Endocrine and Metabolic Late Complications
Time Frame: During a single assessment visit (up to 1 day)
Percentage of participants with at least one endocrine or metabolic late complication, defined as the presence of any endocrine disorder (growth hormone deficiency, hypothyroidism, adrenal insufficiency, hypogonadism) or any metabolic disorder (overweight/obesity defined by body mass index ≥25 kg/m², dyslipidemia defined by abnormal lipid profile, impaired glucose metabolism defined by fasting plasma glucose or HbA1c criteria), assessed by standardized clinical and laboratory evaluation.
Secondary Outcomes
- Prevalence of Endocrine Disorders(During a single assessment visit (up to 1 day))
- Prevalence of Metabolic Disorders(During a single assessment visit (up to 1 day))
- Association Between Tumor Location and Endocrine Disorders(During a single assessment visit (up to 1 day))
- Body Mass Index (BMI)(During a single assessment visit (up to 1 day))
- Fasting Plasma Glucose(During a single assessment visit (up to 1 day))
- LDL Cholesterol(During a single assessment visit (up to 1 day))
- Physical Competence(During a single assessment visit (up to 1 day))