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Recruiting NCT06981156

Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)

Observational Pediatric Brain Tumor Pediatric Spine Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pNANO Assessment.
Who it may be relevant to
Registry conditions: Pediatric Brain Tumor, Pediatric Spine Tumor. Basic parameters: 1 year — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to investigate a neurologic exam scale to provide an objective and more standard way to assess tumor response in pediatric patients with brain and spinal cord tumors.

Detailed description

This study is designed to evaluate inter-observer variability of the pNANO scale when implemented during routine clinic visits for pediatric brain and spine tumor patients. Typically, during a routine clinic visit for patients with pediatric brain and spine tumors, a neurological examination is completed and documented by a provider in clinic notes under the section 'Physical examination', sub-heading 'Neurologic examination.'

For this study, every participant will have neurologic examinations performed by 2 or 3 (if feasible), separate providers on the same day (patient's scheduled provider and one or two additional providers from the Study Team), during a scheduled, routine clinic visit(s). To allow for potential significant discrepancies in exams between two providers, if feasible, a third provider will complete an examination at each visit. Each provider will independently perform the neurologic examination and will document the findings on the pNANO scale scorecard.

Each provider will also record the amount of time it took to complete their neurologic examination. The providers will not communicate with each other about the findings and will be completely blinded to each other's evaluations.

The pNANO scale will be completed at a second clinic visit, between 1-6 months out from the initial assessment. Telemedicine visit evaluations will be allowed for 20% of patients enrolled on study to assess if this scale is feasible via telemedicine. For telemedicine visits, one provider will need to be in clinic to complete the first examination and the second provider will be virtual to complete the second examination on the same day. A third provider would need to be in clinic to complete an examination.

For the second evaluation 1-6 months after the first, the same will apply, one or two providers in clinic to complete the first examination while the second/third provider will be virtual. Providers can include physicians and advanced practice providers of any subspecialty: neurology, hematology-oncology, radiation oncology, neurosurgery, physical medicine and rehabilitation.

Interventions

  • Diagnostic test pNANO Assessment
    pNANO assesses patient gait, strength, cerebellar function, visual fields, visual acuity, facial strength, level of consciousness, extraocular movement, dysarthria, and dysphagia The patient will be assessed by 2-3 different clinicians during each of 2 visits.

Primary outcome measures

  • Inter-observer Variability in pNANO Scores: Difference in Mean Cumulative Scores [Time frame: Visit 1 (baseline), Visit 2 (up to 6 months)]
Secondary outcome measures (2)
  • Feasibility: Clinical Exams that may correlate with pNANO scores [Time frame: Visit 1 (baseline), Visit 2 (up to 6 months)]
  • Feasibility: Inter-observer variability of pNANO scores between in clinic visits and Telemedicine reported as Difference in Mean Cumulative Scores [Time frame: Visit 1 (baseline), Visit 2 (up to 6 months)]

Eligibility criteria

Inclusion criteria

  • greater than or equal to 1 year old
  • must be seen in the pediatric clinic
  • Radiographic or histologic confirmation of a brain or spine tumor at the time of initial diagnosis
  • Patient or parent/guardian must be able to understand the consent and be willing to sign a written informed consent document according to institutional guidelines.

Exclusion criteria

  • none specified

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • American Family Children's Hospital — Madison

Identifiers

NCT: NCT06981156 · 2025-0533 · UW24162 · NCI-2025-03504 · A536755 · Protocol Version 4/3/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗