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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859659
• Other study ID #: KY2022-078-04
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Beijing Tiantan Hospital
• Contact: Yaou Liu, Doctor
• Phone: +86 1059975396
• Email: yaouliu80[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish standardized clinical-MRI -molecular markers database for glioma	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	2022.01-2024.12
Primary	Establish an accurate MRI-based deep-learning model for the prediction of glioma	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	2022.01-2024.12