Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786977
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2021-03-04
Brief Title:
Physiologic Measure of VIPN
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None