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临床试验/NCT06367725
NCT06367725招募中不适用

Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density

University of Aarhus4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
4
主要终点
Area Under the Plasma Concentration Curve (AUC) of Dexamethasone

研究概览

简要总结

The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are:

  • How does the intake of dexamethasone correlate with systemic exposure to dexamethason?
  • Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?

Participants will:

  • Continue to receive the best available therapy for ALL in Western Europe.
  • Have blood samples taken from their central line to measure dexamethasone levels.
  • When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.
  • Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of acute lymphoblastic leukaemia
  • Age 1-17.9 years

排除标准

  • Down syndrome

结局指标

主要结局

Area Under the Plasma Concentration Curve (AUC) of Dexamethasone

时间窗: Repeated during induction, with AUC measurements on days 3, 4, and 15. Blood samples taken before dosing, and after 1, 2, 4, and 6 hours

Blood samples

次要结局

  • Dexamethasone in cerebrospinal fluid(When lumbar punctures are performed according to standard treatment during induction)
  • Vertebral fracture assessment (VFA) by DXA-scan(Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.)
  • Mineral bone density by DXA-scan(Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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