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临床试验/NCT07350382
NCT07350382已完成不适用

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

West China Hospital0 个研究点目标入组 600 人开始时间: 2015年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
600

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhigang Lan

Professor

West China Hospital

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