Children's National Health System
Washington D.C., District of Columbia, 20010, United States
Location status: Recruiting
Location contact
Julia C Finkel, MD
CONTACT
Julia C Finkel, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04786977
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.
Interested in participating?
Request Info6 year–18 year
All sexes
Observational
Washington D.C., District of Columbia, 20010, United States
Location status: Recruiting
Julia C Finkel, MD
CONTACT
Julia C Finkel, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No Intervention
Time frame: 1 Year
The primary objective of this study is the characterization of the neuropathy index in VIPN patients in order to measure VIPN severity.
Time frame: 1 Year
The secondary objective is the correlation between the TNS-PV and the neuropathy index.
Children's National Research Institute
Other
Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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