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临床试验/NCT05859659
NCT05859659招募中不适用

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

Yaou Liu1 个研究点 分布在 1 个国家目标入组 70,000 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70,000
试验地点
1
主要终点
Establish standardized clinical-MRI-molecular markers database for CNS tumors

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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

排除标准

  • (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.

研究组 & 干预措施

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

干预措施: This study does not intervene in this process. (Diagnostic Test)

Prospective cohort of suspected CNS tumors

Intracranial mass lesion comfirmed by preoperative neuroimaging

干预措施: This study does not intervene in this process. (Diagnostic Test)

结局指标

主要结局

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

时间窗: 2022.06-2023.12

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

Establish prospective brain tumor cohort with multiomics information

时间窗: 2022.06.01-2030.12.31

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.

次要结局

  • Accurately predicting the molecular and survival of glioma patients based on a deep learning model(2022.01-2024.12)

研究者

发起方
Yaou Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yaou Liu

Professor

Beijing Tiantan Hospital

研究点 (1)

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