Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents
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
- 是
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
Julia Finkel
Principal Investigator
Children's National Research Institute
