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

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05859659
Collaborator
(none)
3,500
1
36
97.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
3500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical, patHOlogical and Imaging Project of nEuro-oncology (HOPE)
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Molecular pathology of glioma positive

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

Molecular pathology of glioma negative

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

Outcome Measures

Primary Outcome Measures

  1. Establish standardized clinical-MRI -molecular markers database for glioma [2022.01-2024.12]

    1) Collect clinical, MRI and molecular markers data of glioma patients; 2) Establish a standardized tumor labeling database; 3) Establish an automatic segmentation and recognition model of glioma

  2. Establish an accurate MRI-based deep-learning model for the prediction of glioma [2022.01-2024.12]

    1) Build an accurate MRI-based deep-learning model with retrospective data. 2) The multicenter data was used to verify the repeatability and widespread use of the model again

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tiantan Hospital Beijing Beijing China 100053

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yaou Liu, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT05859659
Other Study ID Numbers:
  • KY2022-078-04
First Posted:
May 16, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 17, 2023