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临床试验/NCT04460053
NCT04460053已完成不适用

A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.

Vastra Gotaland Region2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年4月12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
18
试验地点
2
主要终点
Neurofilament light protein measurement in peripheral blood

研究概览

简要总结

A prospective feasibility trial initially including 10 patients to investigate if Neurofilament light protein can be detected in peripheral blood in patients undergoing Isolated Limb Perfusion with chemotherapeutic agents. This biomarker could act as predictive biomarker for neurotoxicity after isolated limb perfusion.

详细描述

In isolated limb perfusion (ILP) neurotoxicity is a known side effect, this is in spite of the fact that a relatively mild hyperthermic temperature is used which should be well tolerated by the nerves and other normal tissues in the limbs. It seems probable that the neurotoxicity observed after ILP results from both a thermal enhancement of drug toxicity combined with a local effect of a high tourniquet pressure that is used to isolate the blood flow. Prevention of regional and systemic toxicity is essential for improving the outcome after the procedure. It is known that both higher doses of melphalan, higher temperatures and longer perfusion time correlates to a higher toxicity. The Wieberdink method is a grading system for the reaction of the normal tissues after ILP and the grading is used as a routine in ILP today. Neurofilament light protein (NfL) is released into the cerebrospinal fluid (CSF) during axonal damage and has been shown to be elevated in different forms of dementia. An NfL assay sensitive enough to measure NfL in blood was recently developed. Its concentration reflects axonal injury in both central and peripheral nervous system disorders.The primary aim of this study is to investigate the possibility to measure neurofilament as a biomarker for peripheral nerve toxicity after isolated limb perfusion.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient scheduled for treatment with isolated limb perfusion
  • Age over 18 years
  • Signed informed consent

排除标准

  • 未提供

结局指标

主要结局

Neurofilament light protein measurement in peripheral blood

时间窗: 4 weeks postoperatively

Neurofilament light protein

次要结局

未报告次要终点

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Roger Olofsson Bagge

Associate professor

Vastra Gotaland Region

研究点 (2)

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