NCT07342699

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. 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

December 1, 2024

Enrollment Period

10 years

First QC Date

December 25, 2025

Last Update Submit

January 7, 2026

Conditions

Gliomas

Keywords

MicrosurgeryPrognostic factorMolecular biomarkerSurvival analysis

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS) time

    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.

    6 months

Secondary Outcomes (3)

  • Progression-Free Survival (PFS)

    6 months

  • Extent of Resection (EOR)

    6 months

  • Rate of Postoperative Complications

    6 months

Study Arms (4)

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

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study Population Description The study group is 450 consecutive patients treated at a single high-volume neuro-oncology center (West China Hospital and its Longquan branch) who underwent primary microsurgical resection for a newly diagnosed glioma that arose wholly within the cerebellum. * \*\*Age span\*\*: 3-78 years (median 38 years); 52.7 % ≤ 40 y, 47.3 % \> 40 y * \*\*Sex\*\*: 244 males (54.3 %), 206 females (45.7 %) * \*\*Tumor origin by cerebellar sub-site\*\* * Cerebellar hemisphere 223 (49.6 %) * Vermis 141 (31.3 %) * Fourth ventricle 67 (14.9 %) * Pontocerebellar-angle region 19 (4.2 %) * \*\*WHO grade at resection\*\*: Low-grade (I-II) 291 (64.7 %); High-grade (III-IV) 159 (35.3 %) * \*\*Pre-operative functional status\*\*: Median KPS 80 (IQR 70-90) * \*\*Molecular profile (full cohort tested)\*\* * IDH-mutant 152 (33.7 %), IDH-wild-type 298 (66.3 %) * 1p/19q codeleted 97 (21.5 %) * MGMT promoter methylated 161 (35.7 %) * TERT promoter mutant 83 (18.4 %)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 15, 2026

Study Start

January 1, 2014

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

January 15, 2026

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)