NCT05859659

Brief Summary

Primary central nervous system (CNS) tumors, the vast majority (\>90%) occurring in the brain and the remainder occurring in the meninges, spinal cord, and cranial nerves, showing an annual incidence of about 6-8 people per 100,000 population but its effects on health-care systems is out of proportion with incidence due to the substantial high rates of morbidity and mortality. Among which, glioma disease is the most common primary malignant CNS tumor, while the glioblastoma that showed the highest degree of malignancy and the worst prognosis accounts for 70-75%. The construction goal of this project is to construct a multivariate retrospective CNS tumor database (over 50,000 cases, including 10,000 glioma) integrating clinical information, preoperative magnetic resonance imaging examination and molecular pathological results, and a prospective glioma database (3,000 cases) integrating advanced magnetic resonance sequences and postoperative follow-up. It aims to form a standardized database integrating magnetic resonance imaging, pathological results, and clinical-prognostic information. Based on the construction of the above standardized database, the specifications for the acquisition of cranial magnetic resonance images, the image segmentation, tumor classification and labeling process, and the expert consensus on database construction and use management of CNS tumors were established. We aim to form a multimodal, large-capacity, high-quality, and rich medical imaging database that conforms to the characteristics of Chinese groups and clinical diagnosis and treatment norms. On this basis, the data are dynamically updated, in-depth mining, and the classification and grading standards of CNS tumor diseases, prognosis judgment criteria and treatment efficacy evaluation system are formulated, and providing comprehensive resources of retrospective data and prospective cohorts for large-scale reasearches, such as classification or treatment intervention predictions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Jan 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jan 2022Dec 2030

Study Start

First participant enrolled

January 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
7.6 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

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

9 years

First QC Date

May 5, 2023

Last Update Submit

March 5, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Establish standardized clinical-MRI-molecular markers database for CNS tumors

    Collecting at least 50,000 retrospective data of CNS tumors patients, including preoperative brain MRI, clinical infromations, histopathology resuluts, and molecular markers, to establish a multi-modal clinical-MRI-molecular database

    2022.06-2023.12

  • Establish prospective brain tumor cohort with multiomics information

    Prospectively include at leaset 10,000 patients with brain space occupying lesions comfirmed by neuroimaging, recording their pre- and postoperative brain MRI, imaging diagnosis, histopathology or molecular pathology results, clinical intervention, treatment effect, and survival time.

    2022.06.01-2030.12.31

Secondary Outcomes (1)

  • Accurately predicting the molecular and survival of glioma patients based on a deep learning model

    2022.01-2024.12

Other Outcomes (1)

  • Establish a large-scale foundation model for brain tumors on MRI

    2024.12-2026.12

Study Arms (2)

Retrospective database of CNS tumors included in the WHO classification (2021)

The subtypes of brain tumors were confirmed by the postoperative histopathology or molecular pathology

Diagnostic Test: This study does not intervene in this process.

Prospective cohort of suspected CNS tumors

Intracranial mass lesion comfirmed by preoperative neuroimaging

Diagnostic Test: This study does not intervene in this process.

Interventions

This study does not intervene in this process.

Prospective cohort of suspected CNS tumorsRetrospective database of CNS tumors included in the WHO classification (2021)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

To reflect the daily practices, this study includes all patients with diffuse glioma at the beginning of the study.

You may qualify if:

  • (1) a clear diagnosis of glioma based on pathological results;
  • (2) The MRI sequence is complete and there are no obvious artifacts in the image;
  • (3) The patient signs an informed consent form

You may not qualify if:

  • (1) Suffering from other neurological diseases;
  • (2) Prior to enrollment, surgery or biopsy, or a history of radiation therapy or chemotherapy;
  • (3) Unable to complete clinical scoring and related laboratory tests, unable to complete follow-up;
  • (4) Unable to tolerate MRI examination; Poor image quality, such as motion artifacts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Neurologic ManifestationsNeoplasmsGliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Yaou Liu, Doctor

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaou Liu, Doctor

CONTACT

Junjie Li, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Clinical and MR data can be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Within 3 years after the end of the trial.
Access Criteria
Neurosurgeon and radiologist who submitting an application to Prof. Liu.

Locations