Predicting Cognitive Dysfunction After Pediatric Posterior Fossa Tumor Surgery

NCT07350382 — Completed, 600 participants, West China Hospital

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

Registry	NCT07350382
Status	Completed
Study type	Observational
Enrollment	600 (Actual)
Sponsor	West China Hospital (Other)
Conditions	Posterior Fossa Tumors, Pediatric Tumor of Brain
Interventions	Not applicable- observational study (Other)
Dates	start 2015-01-01, primary completion 2023-12-30, completion 2024-01-01, first posted 2026-01-20, last updated 2026-01-20
Locations	1 site in China

-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

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+Arms and interventions

Arm	Type	Interventions	Description
pediatric patients who underwent surgical resection of a posterior fossa tumor		Other: Not applicable- observational study	Stratify this cohort into two subgroups based on outcome: Those with long-term cognitive dysfunction (n=172) Those without (n=428)

Not applicable- observational study (Other)

+Outcome measures

Primary outcomes

Incidence of Long-Term Cognitive Dysfunction [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 [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 [1 year after surgery]: Agreement degree between predicted probability and observed frequency of cognitive dysfunction, assessed by Hosmer-Lemeshow test P Value.

+Eligibility

Sex: All, ages: any to 18 Years

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)

Facility	City	Country	Status
West China Hospital of Sichuan University	Chengdu, Sichuan	China