| NCT ID | NCT04786977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Chemotherapy-induced Peripheral Neuropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-09-20 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2021-09-20 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT04786977 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Chemotherapy-induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04786977 currently recruiting?
Yes, NCT04786977 is actively recruiting participants. Visit ClinicalTrials.gov or contact Children's National Research Institute to inquire about joining.
Where is the NCT04786977 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT04786977 clinical trial?
NCT04786977 is sponsored by Children's National Research Institute. The trial plans to enroll 40 participants.