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Completed

NCT Number: NCT07342699

Location-Molecular Integrated Outcomes in 450 Cerebellar Glioma Microsurgical Cases

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.

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Key information

Conditions

Gliomas Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

3 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Progression-Free Survival (PFS)

    Time frame: 6 months

    Time from surgery (or diagnosis) to radiographic or clinical tumor progression. Used to assess efficacy of resection and adjuvant therapies.

  2. Extent of Resection (EOR)

    Time frame: 6 months

    Categorized as:

    Gross Total Resection (GTR; ≥95% tumor removal) Subtotal Resection (STR; <95%) Biopsy only Correlated with survival and recurrence risk.

  3. Rate of Postoperative Complications

    Time frame: 6 months

    Examples:

    Cerebellar mutism syndrome Wound infection / CSF leak Hematoma requiring reoperation Pseudomeningocele Need for ventriculoperitoneal (VP) shunt

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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