Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT06981156
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: