Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Tumor of Brain | Childhood Brain Neoplasm | ALIAS | 0.90 |
| Posterior Fossa Tumors | Posterior Fossa Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Not applicable- observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- pediatric patients who underwent surgical resection of a posterior fossa tumor
- description
- Stratify this cohort into two subgroups based on outcome: Those with long-term cognitive dysfunction (n=172) Those without (n=428)
- interventionNames
- Other: Not applicable- observational study
Primary outcomes (1)
- measure
- Incidence of Long-Term Cognitive Dysfunction
- timeFrame
- 1 year
- description
- 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 (2)
- measure
- Model Discrimination Performance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available