- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07342699
Location-Molecular Integrated Outcomes in 450 Cerebellar Glioma Microsurgical Cases
Microsurgical Outcomes and Prognostic Analysis of 450 Cases of Cerebellar Gliomas: Integrating Pathology, Molecular Biomarkers, and Novel Clinical Insights
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:
- 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?
- 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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sichuan
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Chengdu, Sichuan, China
- West China Hospital of Sichuan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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 %)
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Cerebellar hemisphere
Tumors arise from Cerebellar hemisphere
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Vermis
Tumors arise from Cerebellar Vermis
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Fourth ventricle
Tumors arise from Fourth ventricle
|
|
Pontocerebellar-angle (PCA) region
tumors from Pontocerebellar-angle (PCA) region
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
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. |
6 months
|
|
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 |
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WestChinaH-HX-2025-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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