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

NCT06981156 | Recruiting

• 5 other identifiers: 2025-0533A536755Protocol Version 3/14/25UW24162NCI-2025-03504
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Brain Tumor; Pediatric Spine Tumor

Outcome Measures

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.

  Visit 1 (baseline), Visit 2 (up to 6 months)

Secondary Outcomes (2)

• Feasibility: Clinical Exams that may correlate with pNANO scores

  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

  Visit 1 (baseline), Visit 2 (up to 6 months)

Study Arms (1)

Pediatric Brain and Spine Tumor Patients

Diagnostic Test: pNANO Assessment

Interventions

pNANO Assessment DIAGNOSTIC_TEST

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.

Also known as: Pediatric Neuro-Oncology

Pediatric Brain and Spine Tumor Patients

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric brain or spine tumor patients greater than or equal to 1 year old.

You may qualify if:

• 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.

You may not qualify if:

• none specified

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Study Officials

• Austin Stuckert, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)