NCT07608003

Brief Summary

A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q. This prospective multicenter study will validate the model's accuracy in preoperative molecular subtyping and its value in prognostic assessment and clinical decision-making across multiple neurosurgical centers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started May 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
May 2026Dec 2030

First Submitted

Initial submission to the registry

May 7, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 27, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

May 7, 2026

Last Update Submit

May 25, 2026

Conditions

Gliomas Harboring IDH1 and/or IDH2 MutationsGlioma Glioblastoma MultiformeGlioma of BrainstemGlioma, Diffuse Midline, H3K27M-mutantGlioma : Oligodendroglioma or AstrocytomaGliomas

Keywords

Midline gliomasMolecular diagnosisFoundation modelPrognosis prediction

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy for midline glioma molecular subtypes

    Model predictions compared with postoperative histopathology and molecular testing (gold standard). Performance metrics include AUC, F1 score, sensitivity, specificity, and accuracy.

    Perioperative

Eligibility Criteria

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

Patients with diffuse gliomas located in the intracranial midline.

You may qualify if:

  • Patients with diffuse gliomas were pathologically and molecularly diagnosed.
  • The clinical case data of all patients were complete.
  • Patients underwent preoperative MRI examination.

You may not qualify if:

  • The tumor is not located in the intracranial midline.
  • Cases in which MRI were incomplete or with significant noise and artifacts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

GlioblastomaGliomaAstrocytoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Gong Xuan, MD.

CONTACT

0086-731-8975-3037gong.xuan@csu.edu.cn

Shuwen Kuang, MD.

CONTACT

0086-13367494221228102171@csu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 27, 2026

Study Start

May 10, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

May 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)