Predicting Cognitive Dysfunction After Pediatric Posterior Fossa Tumor Surgery

NCT07350382 | Completed DMC

• 1 other identifier: WestChinaH-HX-2025-012
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Posterior Fossa Tumors; Pediatric Tumor of Brain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Long-Term Cognitive Dysfunction

  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.

  1 year

Secondary Outcomes (2)

• Model Discrimination Performance

  1 year post-surgery

• Model Calibration Accuracy

  1 year after surgery

Study Arms (1)

pediatric patients who underwent surgical resection of a posterior fossa tumor

Stratify this cohort into two subgroups based on outcome: Those with long-term cognitive dysfunction (n=172) Those without (n=428)

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

pediatric patients who underwent surgical resection of a posterior fossa tumor

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study includes 600 children aged 0-18 years who underwent surgical resection of a primary posterior fossa tumor (e.g., medulloblastoma, ependymoma, or pilocytic astrocytoma). All participants had preoperative brain MRI with diffusion tensor imaging (DTI), received standard-of-care treatment, and completed comprehensive neuropsychological assessments at approximately 1 year post-surgery. The cohort represents a real-world pediatric neuro-oncology population treated at multiple tertiary care centers.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Infratentorial Neoplasms; Cognitive Dysfunction; Cerebellar Cognitive Affective Syndrome

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebellar Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 20, 2026
• Study Start: January 1, 2015
• Primary Completion: December 30, 2023
• Study Completion: January 1, 2024
• Last Updated: January 20, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)