Chemotherapy-induced Peripheral NeuropathyNCT04786977
Physiologic Measure of VIPN
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 30 patients and 10 healthy volunteers will be enrolled for this study.
Who may be able to join
- 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.
Who cannot join
- have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Health System
Washington D.C., District of Columbia, 20010
Julia C Finkel, MD, (202)476-4867, jfinkel@cnmc.org
Julia C Finkel, MD
About this study
Official title: Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents
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.
- Being tested
- No Intervention, Observational Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention, Observational StudyOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| VIPN Patients | Not described Receives: Other: No Intervention, Observational Study | |
| Healthy Volunteers | Not described Receives: Other: No Intervention, Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Secondary outcomes (1)
Correlation of neuropathy index with the TNS-PV
The secondary objective is the correlation between the TNS-PV and the neuropathy index.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start20 Sep 2021
- Primary completionMay 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Finkel, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786977
- Sponsor's protocol ID
- Pro00015693
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2021
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents
- ClinicalTrials.gov ID
- NCT04786977
- Acronym / sponsor ID
- Pro00015693
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIPN Patients | – | Other: No Intervention, Observational Study |
| Healthy Volunteers | – | Other: No Intervention, Observational Study |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 30 patients and 10 healthy volunteers will be enrolled for this study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention, Observational StudyNo Intervention | Other | Healthy Volunteers, VIPN Patients |
Primary outcome
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.
1 secondary outcome
Correlation of neuropathy index with the TNS-PV
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of neuropathy index in patients with VIPN (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.