GliomasNCT07342699
Location-Molecular Integrated Outcomes in 450 Cerebellar Glioma Microsurgical Cases
An observational study of Gliomas, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Gliomas
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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 %)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gliomas
- Keywords
- Microsurgery, Prognostic factor, Molecular biomarker, Survival analysis
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Progression-Free Survival (PFS)
Time from surgery (or diagnosis) to radiographic or clinical tumor progression. Used to assess efficacy of resection and adjuvant therapies.
Measured: 6 months
Extent of Resection (EOR)
Categorized as:
Gross Total Resection (GTR; ≥95% tumor removal) Subtotal Resection (STR; <95%) Biopsy only Correlated with survival and recurrence risk.
Measured: 6 months
Rate of Postoperative Complications
Examples:
Cerebellar mutism syndrome Wound infection / CSF leak Hematoma requiring reoperation Pseudomeningocele Need for ventriculoperitoneal (VP) shunt
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2014
- Primary completion1 Jan 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomasStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342699
- Sponsor's protocol ID
- WestChinaH-HX-2025-09
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microsurgical Outcomes and Prognostic Analysis of 450 Cases of Cerebellar Gliomas: Integrating Pathology, Molecular Biomarkers, and Novel Clinical Insights
- ClinicalTrials.gov ID
- NCT07342699
- Acronym / sponsor ID
- WestChinaH-HX-2025-09
- Conditions
- Gliomas
- Keywords
- Microsurgery, Prognostic factor, Molecular biomarker, Survival analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 %)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 6 months
Extent of Resection (EOR)
Time frame: 6 months
Rate of Postoperative Complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gliomas, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) time (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.