Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
none specified
Trial population
Pediatric brain or spine tumor patients greater than or equal to 1 year old.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
pNANO Assessment
Diagnostic testpNANO 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.
Treatment groups
252 Participants
are divided into 1 treatment groupGroup A: Pediatric Brain and Spine Tumor Patients1 intervention
Trial outcomes
Primary outcomes
1
Inter-observer Variability in pNANO Scores: Difference in Mean Cumulative Scores
The Pediatric Neurologic Assessment in Neuro-Oncology (pNANO) is scored in multiple domains: - strength, level of consciousness, and gait domains (each individually scored 0-3) * facial strength, cerebellar function, visual fields, extraocular movements, dysphagia, and dysarthria domains (each individually scored 0-2) * visual acuity domain scored from 0-1 If summed, cumulative scores range from 0 (normal) to 22 (inability to function in each relevant domain) Investigators will explore variability across all domains.
Time frame
Visit 1 (baseline), Visit 2 (up to 6 months)Secondary outcomes
1
Feasibility: Clinical Exams that may correlate with pNANO scores
Investigators will explore whether pNANO scores (individual domains or cumulative scores) correlate with clinical exams.
Time frame
Visit 1 (baseline), Visit 2 (up to 6 months)2
Feasibility: Inter-observer variability of pNANO scores between in clinic visits and Telemedicine reported as Difference in Mean Cumulative Scores
A subset of participants (approximately 20%) will be assessed remotely to study any impact telemedicine has on pNANO scoring. If summed, cumulative scores range from 0 (normal) to 22 (inability to function in each relevant domain). Investigators will explore variability across all domains.
Time frame
Visit 1 (baseline), Visit 2 (up to 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov