Location-Molecular Integrated Outcomes in 450 Cerebellar... | NCT07342699

Studies
Location-Molecular Integrated Outcomes in 450 Cerebellar Glioma Microsurgical Cases

NCT07342699

Sponsor

West China Hospital

Status

Completed

Last Update Posted

Jan 15, 2026Actual

Enrollment

450Actual

Phase

Not provided

Conditions

Gliomas

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Jun 1, 2024Actual

First Submitted Date

Dec 25, 2025

First Submission Date that Met QC Criteria

Jan 7, 2026

First Posted Date

Jan 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2026

Last Update Posted Date

Jan 15, 2026Actual

Description Module

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:

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Progression-Free Survival (PFS)	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

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 %)

Sampling Method

Non-Probability Sample

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type