Recruiting

Vincristine Evaluation

Sponsor:

Children's National Research Institute

Code:

NCT04786977

Conditions

Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Accepted

Interventions

No Intervention, Observational Study

Study Details

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study ID

NCT04786977

Start date

Sep 20, 2021

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

VIPN Patients

Healthy Volunteers

Interventions

No Intervention, Observational Study

No Intervention

Primary outcome measure

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

Central Contacts and Locations

Locations

Children's National Health System

Recruiting

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

Contacts

Principal Investigator:

Julia C Finkel, MD

More Information

Sponsor

Children's National Research Institute

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-07-24.