NCT07350382Completed
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 · Last updated 20 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 600 (actual)
- First submitted
- 5 Jan 2026
- Start date
- 1 Jan 2015
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- West China Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT07350382
What you commit to
- Study type: Observational
- Participants enrolled: 600
- From 1 Jan 2015 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior cranial irradiation or chemotherapy before posterior fossa surgery
Other illness
- Pre-existing neurological or neurodevelopmental disorders (e.g., autism, intellectual disability, cerebral palsy)
Other
- 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)
Who the study is looking for
- 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
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.