Pediatric Brain TumorNCT06981156
Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)
An observational study of Pediatric Brain Tumor and Pediatric Spine Tumor, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pediatric Brain Tumor, Pediatric Spine Tumor
- What is being tested?
- pNANO Assessment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric brain or spine tumor patients greater than or equal to 1 year old.
Who may be able to join
- 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.
Who cannot join
- none specified
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
American Family Children's Hospital
Madison, Wisconsin, 53792
About this study
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.
Read the 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.
- Conditions
- Pediatric Brain Tumor, Pediatric Spine Tumor
- Being tested
- pNANO Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pNANO AssessmentDiagnostic test
Also called Pediatric Neuro-Oncology
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Brain and Spine Tumor Patients | Not described Receives: Diagnostic Test: pNANO Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 (baseline), Visit 2 (up to 6 months)
Secondary outcomes (2)
Feasibility: Clinical Exams that may correlate with pNANO scores
Investigators will explore whether pNANO scores (individual domains or cumulative scores) correlate with clinical exams.
Measured: 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
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.
Measured: Visit 1 (baseline), Visit 2 (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start13 May 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Brain TumorStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Austin Stuckert, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981156
- Sponsor's protocol ID
- 2025-0533
- Other IDs
- UW24162, NCI-2025-03504, A536755, Protocol Version 4/3/2026
- Status last verified
- Jul 2026
- First submitted
- 12 May 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)
- ClinicalTrials.gov ID
- NCT06981156
- Acronym / sponsor ID
- 2025-0533
- Conditions
- Pediatric Brain Tumor, Pediatric Spine Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Brain and Spine Tumor Patients | – | Diagnostic Test: pNANO Assessment |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric brain or spine tumor patients greater than or equal to 1 year old.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pNANO AssessmentAlso: Pediatric Neuro-OncologypNANO 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. | Diagnostic test | Pediatric Brain and Spine Tumor Patients |
Primary outcome
Inter-observer Variability in pNANO Scores: Difference in Mean Cumulative Scores
Time frame: Visit 1 (baseline), Visit 2 (up to 6 months)
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Austin Stuckert, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Brain Tumor and Pediatric Spine Tumor, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-observer Variability in pNANO Scores: Difference in Mean Cumulative Scores (time frame: Visit 1 (baseline), Visit 2 (up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.