Physiologic Measure of VIPN

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT04786977
Status
Recruiting
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Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • No Intervention, Observational Study — OTHER
    No Intervention

Study Details

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.

Key Dates

Start date
Sep 20, 2021
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 1, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: VIPN Patients
  • Arm: Healthy Volunteers

Primary Outcome Measure

Characterization of neuropathy index in patients with VIPN [ Time Frame: 1 Year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National Health SystemWashington D.C.District of Columbia20010
Julia C Finkel, MD
[email protected]
(202)476-4867
Julia C Finkel, MD (PRINCIPAL_INVESTIGATOR)

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