Predicting Cognitive Dysfunction After Pediatric Posterior Fossa Tumor Surgery

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

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Key information

Conditions

Posterior Fossa Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebellar Cognitive Affective Syndrome Cerebellar Diseases Cognition Disorders Cognitive Dysfunction Infratentorial Neoplasms Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurocognitive Disorders Pediatric Tumor of Brain

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Not applicable- observational study

Other

Primary outcomes

Incidence of Long-Term Cognitive Dysfunction

Time frame: 1 year

Presence 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 outcomes

Model Discrimination Performance

Time frame: 1 year post-surgery

Area Value under the receiver operating characteristic curve (AUC) of the final predictive model (nomogram) in the internal validation cohort.
Model Calibration Accuracy

Time frame: 1 year after surgery

Agreement degree between predicted probability and observed frequency of cognitive dysfunction, assessed by Hosmer-Lemeshow test P Value.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2024
First posted: Jan 20, 2026
Registry last updated: Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed