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临床试验/NCT04786977
NCT04786977招募中不适用

Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents

Children's National Research Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Characterization of neuropathy index in patients with VIPN

研究概览

简要总结

The purpose of this study is the development of a physiologic endpoint using a novel technology that would provide an objective, easy to use and more sensitive assessment of VIPN in children and adolescents. The ability to more easily detect and monitor VIPN, even before it is clinically evident, would facilitate optimizing the dosing of vincristine for maximal disease response while minimizing the risk of lifelong functional deficits affecting quality of life. This approach would also enable the development of specific therapies to minimize or eliminate the occurrence of VIPN in children and adolescents. This is a single site study that aims to develop a novel device to evaluate and characterize vincristine-induced neuropathic pain. The investigators will enroll patients with ALL following the Delayed Intensification (DI) phase of treatment. At each study visit, the investigators will evaluate the nPRD as well as the TNS-PV. The nPRD will inform the neuropathy index which will be used to compare to the TNS-PV. We anticipate a correlation between the two.

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 6-18 years of age at the start of the study, are receiving vincristine in DI (clinical study population) and are willing and able to provide informed consent or assent to study participation.

排除标准

  • have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.

研究组 & 干预措施

Healthy Volunteers

干预措施: No Intervention, Observational Study (Other)

VIPN Patients

干预措施: No Intervention, Observational Study (Other)

结局指标

主要结局

Characterization of neuropathy index in patients with VIPN

时间窗: 1 Year

The primary objective of this study is the characterization of the neuropathy index in VIPN patients in order to measure VIPN severity.

次要结局

  • Correlation of neuropathy index with the TNS-PV(1 Year)

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Finkel

Principal Investigator

Children's National Research Institute

研究点 (2)

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