Protocol No.UW24162
Principal InvestigatorStuckert, Austin
PhaseN/A
Age GroupBoth
ClinicalTrials.GovNCT06981156 (Click to jump to clinicaltrials.gov)
Management Group(s) Pediatric Oncology

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

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

Objective
Primary:



    To determine the inter-observer variability of the neurologic domains of the Neurologic Assessment in pediatric NeuroOncology (pNANO) scale as a parameter of its overall reliability.

Secondary:


    To evaluate the feasibility of assessing the neurologic status of pediatric brain and spine tumor patients evaluated during a routine office visit using the pNANO scale.

Exploratory:


    To assess pNANO scale inter-observer variability among patients based on their radiologic assessment (stable, progressed or improved) at the time of clinical evaluation using the pNANO scale.

    To assess the overall score of the pNANO scale relative to disease status assessment (stable, progressed or improved) at the time of clinical evaluation.

    To assess the visual assessment scores of pNANO relative to formal ophthalmological assessments.

    To assess the overall feasibility, inter-observer variability and domain specific concordance rates of the pNANO scale during a routine telemedicine visit.

Treatment For this study, every participant will have standard of care 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). Results from these standard of care neurological examinations will be recorded and used to complete the pNANO scale. To allow for potential significant discrepancies in exams between two providers, if feasible, we will have a third provider complete an examination at each visit. Each provider will independently perform the neurologic examination and will document the findings on the pNANO scale scorecard. (A neurologic assessment will also be documented by the patient’s scheduled provider in the standard clinic note format). Each provider will also record the amount of time it took to complete their neurologic examination.

Key Eligibility Potential participants meeting the following eligibility criteria will be identified by their providers and will be presented the option to participate in this trial:



    >/= 1 year and
    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.

Applicable Disease Sites
Brain/Central Nervous System

Participating Institutions
UW Health University Hospital