Skip to content

Predicting Cognitive Dysfunction After Pediatric Posterior Fossa Tumor Surgery

Development and Internal Validation of a Machine Learning-Enhanced Nomogram to Stratify Risk of Chronic Cognitive Impairment Following Pediatric Posterior Fossa Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07350382
Enrollment
600
Registered
2026-01-20
Start date
2015-01-01
Completion date
2024-01-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Tumor of Brain, Posterior Fossa Tumors

Keywords

Pediatric posterior fossa tumor, Cognitive dysfunction, Cerebellar cognitive affective syndrome, Predictive model, Machine learning, Nomogram, Calibration curve

Brief summary

The goal of this observational study is to develop and validate a clinical prediction model to identify risk factors for long-term cognitive dysfunction in children (ages 0-18 years) who have undergone surgical resection of a posterior fossa tumor. The main questions it aims to answer are: Can a combination of preoperative and postoperative clinical, surgical, and neuroimaging factors accurately predict which children will develop long-term cognitive dysfunction after posterior fossa tumor surgery? Is white matter integrity-specifically fractional anisotropy (FA) of the superior cerebellar peduncle (SCP)-a key independent predictor of cognitive outcomes? Researchers will compare children who developed long-term cognitive dysfunction (cases) to those who did not (controls) to see if differences in imaging biomarkers (e.g., SCP FA, fMRI abnormalities), tumor characteristics (e.g., location, volume, histology), treatment factors (e.g., radiotherapy, surgical approach), and demographic variables (e.g., age) are associated with cognitive outcomes. Participants were not asked to perform any tasks or receive any interventions as part of this study, because it is a retrospective analysis of existing medical records and imaging data. Data collected included: Preoperative and postoperative brain MRI and DTI scans Tumor pathology and surgical reports Treatment details (e.g., radiation, chemotherapy) Neuropsychological assessment results at 1-year follow-up

Interventions

OTHERNot applicable- observational study

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Age 0-18 years at time of surgery * Histopathologically confirmed primary posterior fossa tumor (e.g., medulloblastoma, ependymoma, pilocytic astrocytoma) * Underwent surgical resection of the tumor at the hospital * Availability of preoperative brain MRI and diffusion tensor imaging (DTI) * Completed standardized neuropsychological assessment at approximately 1 year post-surgery

Exclusion criteria

* Pre-existing neurological or neurodevelopmental disorders (e.g., autism, intellectual disability, cerebral palsy) * History of prior cranial irradiation or chemotherapy before posterior fossa surgery * Incomplete clinical, imaging, or follow-up data required for model variables * Tumor recurrence or progression before 1-year cognitive assessment * Non-posterior fossa primary brain tumors (e.g., supratentorial gliomas)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Long-Term Cognitive Dysfunction1 yearPresence or absence of long-term cognitive dysfunction, defined as a full-scale IQ (FSIQ) score \< 85 or significant impairment in ≥2 cognitive domains (e.g., attention, memory, executive function, processing speed) on standardized neuropsychological assessment at 1-year follow-up.

Secondary

MeasureTime frameDescription
Model Discrimination Performance1 year post-surgeryArea Value under the receiver operating characteristic curve (AUC) of the final predictive model (nomogram) in the internal validation cohort.
Model Calibration Accuracy1 year after surgeryAgreement degree between predicted probability and observed frequency of cognitive dysfunction, assessed by Hosmer-Lemeshow test P Value.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026