NCT04308642已完成不适用
Pilot Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy (Kid-MaCare Oncology)
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年10月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in serum uromodulin levels (ng/ml)
研究概览
简要总结
This study is to investigate blood and urine kidney injury markers (especially Uromodulin) in pediatric cancer patients treated with nephrotoxic chemotherapy. Uromodulin is a marker to detect and monitor tubular injury and renal function.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent by their-selves (≥ 14 years) or their legal representatives (< 14 years or in case of lacking capacity of judgement)
- •cancer diagnosis, that indicates a nephrotoxic chemotherapy including the drugs High Dose MTX (HD-MTX), ifosfamide, cis- and carboplatin.
排除标准
- •critically-ill patients with inotropic and/or vasopressor drugs
- •signs of severe Sepsis
- •receiving other nephrotoxic drugs parallel to the chemotherapy cycle
结局指标
主要结局
Change in serum uromodulin levels (ng/ml)
时间窗: from baseline (i.e. prior to first nephrotoxic chemotherapy cycle) to post-baseline (i.e. at the end of the first nephrotoxic chemotherapy cycle exposure); depending on chemotherapy protocol (maximally 24 - 72 hours)
Change in serum uromodulin levels (ng/ml)
次要结局
- Change in serum uromodulin levels (ng/ml)(at baseline (i.e. prior to first nephrotoxic chemotherapy cycle) and post-baseline (i.e. before, dur-ing and at the end of each nephrotoxic chemotherapy cycle),maximally 6- 9 months)
- Change in urine uromodulin levels (ng/ml)(at baseline (i.e. prior to first nephrotoxic chemotherapy cycle) and post-baseline (i.e. before, dur-ing and at the end of each nephrotoxic chemotherapy cycle), maximally 6- 9 months)
研究者
研究点 (1)
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