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Clinical Trials/NCT07342699
NCT07342699
Completed
Not Applicable

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

West China Hospital1 site in 1 country450 target enrollmentStarted: January 1, 2014Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
450
Locations
1
Primary Endpoint
Overall survival (OS) time

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
3 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Arms & Interventions

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

Outcomes

Primary Outcomes

Overall survival (OS) time

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhigang Lan

Professor

West China Hospital

Study Sites (1)

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