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临床试验/NCT07342699
NCT07342699已完成不适用

Microsurgical Outcomes and Prognostic Analysis of 450 Cases of Cerebellar Gliomas: Integrating Pathology, Molecular Biomarkers, and Novel Clinical Insights

West China Hospital1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2014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
450
试验地点
1
主要终点
Overall survival (OS) time

研究概览

简要总结

The goal of this observational study is to learn if refined anatomical location-combined with molecular biomarkers-can predict surgical success and long-term survival in 450 adults and children with cerebellar gliomas who underwent microsurgical resection at a single center between 2014 and 2024. The main questions it aims to answer are:

  1. Does tumor location (cerebellar hemisphere, vermis, fourth ventricle, or pontocerebellar-angle region) independently influence extent of resection and overall survival after adjustment for WHO grade and molecular profile?
  2. Among IDH-wild-type low-grade gliomas, does gross-total resection plus early adjuvant radiotherapy improve 5-year overall and progression-free survival compared with lesser resection or radiotherapy omission?

Researchers compared four anatomical subgroups and multiple molecular subtypes (IDH, 1p/19q, MGMT, TERT, BRAF V600E) to quantify location-specific resection rates, complication rates, and survival outcomes. Participants underwent standardized pre-operative imaging, microsurgical resection with intra-operative monitoring when indicated, post-operative MRI within 48 h to quantify residual tumor, and longitudinal clinical and radiographic follow-up every 3-12 months for up to 10 years.

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
3 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pathologically proven cerebellar glioma (hemisphere, vermis, fourth ventricle, or pontocerebellar-angle region) per 2021 WHO CNS classification
  • First microsurgical resection performed at our center between January 2014 and January 2024
  • Age ≥ 3 years at surgery
  • Pre-operative Karnofsky Performance Status (KPS) recorded
  • Availability of post-operative contrast MRI for resection-extent calculation
  • Minimum required molecular data: IDH1/2 status (immunohistochemistry ± sequencing)
  • Continuous follow-up ≥ 6 months after surgery (out-patient visits or telephone confirmation)

排除标准

  • Brain-stem glioma with secondary cerebellar invasion
  • Recurrent or metastatic glioma
  • Previous cranial radiation or glioma surgery at another institution
  • Palliative resection (< 20 % of tumor volume removed)
  • Missing post-operative MRI or insufficient tissue for mandatory IDH testing
  • Follow-up < 6 months or lost to follow-up before 6-month landmark

研究组 & 干预措施

Cerebellar hemisphere

Tumors arise from Cerebellar hemisphere

Vermis

Tumors arise from Cerebellar Vermis

Fourth ventricle

Tumors arise from Fourth ventricle

Pontocerebellar-angle (PCA) region

tumors from Pontocerebellar-angle (PCA) region

结局指标

主要结局

Overall survival (OS) time

时间窗: 6 months

the number of months from the date of microsurgical resection to the date of death from any cause or last confirmed follow-up, measured for all 450 enrolled patients and compared across the four anatomical cerebellar locations and the predefined molecular sub-groups.

次要结局

  • Progression-Free Survival (PFS)(6 months)
  • Extent of Resection (EOR)(6 months)
  • Rate of Postoperative Complications(6 months)

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

研究点 (1)

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