Clinical, patHOlogical and Imaging Project of nEuro-oncology (HOPE)

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Brain Tumor; Brain (Nervous System) Cancers
• Intervention / Treatment: Diagnostic test: This study does not intervene in this process.

Detailed Description

Glioma disease is the most common primary malignant tumor of the central nervous system, with an annual incidence of about 3-8 people per 100,000 population, of which glioblastoma with 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 glioma database (3000 cases) integrating clinical information, magnetic resonance imaging examination and molecular pathological results, and a prospective glioma database (500 cases) integrating advanced magnetic resonance sequences. It aims to form a standardized database integrating clinical-prognostic information, magnetic resonance imaging and pathological results. Based on the construction of the above standardized database, the specifications for the acquisition of cranial magnetic resonance images, the image segmentation and labeling process, and the expert consensus on database construction and use management of glioma diseases were established. 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 glioma diseases, prognosis judgment criteria and treatment efficacy evaluation system are formulated.

• Study Type: Observational
• Enrollment (Estimated): 70000

Contacts and Locations

• Study Contact: Name: Yaou Liu, Doctor; Phone Number: +86 1059975396; Email: yaouliu80@163.com
• Study Contact Backup: Name: Junjie Li, Master; Phone Number: 86-19834515120; Email: 19834515120@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Yaou Liu, PhD; Email: yaouliu80@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• (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

Exclusion Criteria:

• (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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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.; This study does not intervene in this process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accurately predicting the molecular and survival of glioma patients based on a deep learning model	Build a MRI-based deep-learning model to predict molecular and survival on glioma.	2022.01-2024.12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish a large-scale foundation model for brain tumors on MRI	Developing artificial intelligence (AI) tools for brain tumors diagnosis and prediction using the retrospective MRI database with paired imaging reports and histopathological labeling, and conducting internal tests on the prospective cohort to evaluate AI model performance.	2024.12-2026.12

Collaborators and Investigators

• Sponsor: Yaou Liu
• Investigators: Principal Investigator: Yaou Liu, Doctor, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Glioma, Multi-center, MRI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Central Nervous System Neoplasms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Neurologic Manifestations; Glioma; Brain Neoplasms
• Other Study ID Numbers: KY2022-078-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical and MR data can be shared.
• IPD Sharing Time Frame: Within 3 years after the end of the trial.
• IPD Sharing Access Criteria: Neurosurgeon and radiologist who submitting an application to Prof. Liu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No