Physiologic Measure of VIPN

NCT04786977 | Recruiting

• 1 other identifier: Pro00015693
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Characterization of neuropathy index in patients with VIPN

  The primary objective of this study is the characterization of the neuropathy index in VIPN patients in order to measure VIPN severity.

  1 Year

Secondary Outcomes (1)

• Correlation of neuropathy index with the TNS-PV

  1 Year

Study Arms (2)

VIPN Patients

Other: No Intervention, Observational Study

Healthy Volunteers

Other: No Intervention, Observational Study

Interventions

No Intervention, Observational Study OTHER

No Intervention

Healthy Volunteers; VIPN Patients

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

30 patients and 10 healthy volunteers will be enrolled for this study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Health System

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

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: September 20, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)