Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Prevalence of Endocrine and Metabolic Late Complications
研究概览
简要总结
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.
详细描述
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,
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Endocrine and Metabolic Late Effects Assessment (Diagnostic Test)
结局指标
主要结局
Prevalence of Endocrine and Metabolic Late Complications
时间窗: 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.
次要结局
- 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))