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NCT Number: NCT04786977

Physiologic Measure of VIPN

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.

Recruiting

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location status: Recruiting

Location contact

Julia C Finkel, MD

CONTACT

[email protected]

(202)476-4867

Julia C Finkel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.

Treatment and study plan

no intervention, observational study

Other

No Intervention

Primary outcomes

  1. Characterization of neuropathy index in patients with VIPN

    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.

Secondary outcomes

  1. Correlation of neuropathy index with the TNS-PV

    Time frame: 1 Year

    The secondary objective is the correlation between the TNS-PV and the neuropathy index.

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2021
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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