Actively Recruiting
Physiologic Measure of VIPN
Led by Children's National Research Institute · Updated on 2026-04-06
40
Participants Needed
1
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Physiologic Measure of VIPN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 6 and 18 years old at the start of the study
- Currently receiving vincristine chemotherapy during the Delayed Intensification phase
- Willing and able to provide informed consent or assent to participate
You will not qualify if you...
- Have an eye condition that prevents using pupillometry
- Are hemodynamically unstable
- Are pregnant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's National Health System
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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