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
- Number and Percentage of Participants With at Least One Endocrine or Metabolic Late Effect
研究概览
简要总结
This prospective, single-group interventional study evaluates endocrine and metabolic late effects in survivors of primary brain tumors treated during childhood. According to the study protocol, participants were prospectively assigned to undergo the Study-Specific Endocrine and Metabolic Late-Effects Assessment. The assessment included anthropometric measurements, repeated blood pressure measurements, clinical endocrine evaluation, fasting laboratory testing, and protocol-defined bone and vascular assessments. The purpose of the study was to identify the frequency and severity of endocrine and metabolic late effects and to evaluate their associations with tumor characteristics, previous cancer treatment, age at diagnosis, and physical functioning.
详细描述
Survivors of primary brain tumors treated during childhood may develop endocrine, metabolic, neurological, psychological, and cardiovascular late effects several years after completion of cancer treatment.
This prospective, single-group interventional study included individuals who had been treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years and who had survived for at least 5 years after diagnosis.
Following enrollment and informed consent, all participants were prospectively assigned, according to the study protocol, to undergo the same Study-Specific Endocrine and Metabolic Late-Effects Assessment. Participation in the study determined the standardized manner and intensity with which the protocol-defined procedures were performed; participants would not otherwise necessarily have received the same assessment package during routine clinical follow-up.
The protocol-defined assessment included review of medical history and previous cancer treatment, measurement of body weight, height, waist and hip circumference, arm span and sitting height, repeated blood pressure measurements, clinical assessment of endocrine and pubertal status, and fasting laboratory testing of endocrine and metabolic markers.
The study-specific assessment also included vascular evaluation by measurement of carotid intima-media thickness.When the relevant results were not already available, dual-energy X-ray absorptiometry for the assessment of bone mineral density and body composition, and pulse wave velocity assessment, were performed or arranged according to the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years.
- •Survival for at least 5 years after the diagnosis of a primary brain tumor.
- •Written informed consent provided by the participant or, when applicable, by a parent or legal guardian.
排除标准
- •Failure to meet the inclusion criteria.
- •Absence of written informed consent from the participant or, when applicable, from a parent or legal guardian.
研究组 & 干预措施
Study-Specific Endocrine and Metabolic Late-Effects Assessment
Participants were prospectively assigned to undergo the protocol-defined endocrine and metabolic late-effects assessment. The assessment included anthropometric measurements, repeated blood pressure measurements, clinical endocrine evaluation, fasting laboratory testing, and protocol-defined bone and vascular assessments.
干预措施: Study-Specific Endocrine and Metabolic Late-Effects Assessment (Other)
结局指标
主要结局
Number and Percentage of Participants With at Least One Endocrine or Metabolic Late Effect
时间窗: Baseline
Number and percentage of participants with at least one endocrine or metabolic late effect identified by the protocol-defined Study-Specific Endocrine and Metabolic Late-Effects Assessment. Late effects were identified using medical history, clinical endocrine evaluation, anthropometric measurements, repeated blood pressure measurements, and laboratory findings, including growth-related, thyroid, gonadal, adrenal, glucose, insulin, lipid, liver, and vitamin D parameters.
次要结局
- Number and Percentage of Participants With Endocrine or Metabolic Late Effects by Tumor and Treatment Characteristics(Baseline)