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Predicting Cognitive Dysfunction After Pediatric Posterior Fossa Tumor Surgery

N/ACompletedNCT07350382
West China Hospital600 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Posterior Fossa TumorsPediatric Tumor of Brain

Interventions

Not applicable- observational studyOTHER

Eligibility

Sex: ALLMax age: 18 Years
Medical Language ↔ Plain English
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)

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Model Discrimination Performance

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

Time frame: 1 year post-surgery

Model Calibration Accuracy

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

Time frame: 1 year after surgery

Data from ClinicalTrials.gov

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