Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China
Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China.
BMJ Open. 2021 Jan 17;11(1):e040055. doi: 10.1136/bmjopen-2020-040055.
Brain tumours encompass a complex group of intracranial tumours that mostly affect young adults and children, with a high incidence rate and poor prognosis. It remains impossible to systematically collect data on patients with brain tumours in China and difficult to perform in-depth analysis on the status of brain tumours, medical outcomes or other important medical issues through a multicentre clinical study. This study describes the first nation-wide data platform including the entire spectrum of brain tumour entities, which will allow better management and more efficient application of patient data in China.
The National Brain Tumor Registry of China (NBTRC) is a registry of real-word clinical data on brain tumours. It is established and managed by the China National Clinical Research Center for Neurological Diseases and administered by its scientific and executive committees. The 54 participating hospitals of the NBTRC are located in 27 provinces/municipalities, performing more than 40 000 brain tumour surgeries per year. The data consist of in-hospital medical records, images and follow-up information after discharge. Data can be uploaded in three ways: the web portal, remote physical servers and offline software. The data quality control scheme is seven-dimensional. Each participating hospital could focus on a single pathology subtype and public subtypes of brain tumour for which they expect to conduct related multicentre clinical research. The standardised workflow to conduct clinical research is based on the benefit-sharing mechanism. Data collection will be conducted continuously from 1 February 2019 to 31 January 2024.
Informed consent will be obtained from all participants. Consent for the adolescents' participation will be also obtained from their guardians via written consent. The results will be published in professional journals, in both Chinese and English.
Chinese Clinical Trial Registry (ChiCTR1900021096).
脑肿瘤包括一组复杂的颅内肿瘤，主要影响年轻人和儿童，发病率高，预后差。在中国，系统收集脑肿瘤患者的数据仍然是不可能的，也难以通过多中心临床研究对脑肿瘤的状况、医疗结果或其他重要医疗问题进行深入分析。本研究描述了第一个包括所有脑肿瘤实体的全国性数据平台，这将使中国更好地管理和更有效地应用患者数据。
中国国家脑肿瘤登记中心（NBTRC）是一个脑肿瘤真实世界临床数据登记处。它由中国国家神经系统疾病临床医学研究中心建立和管理，由其科学和执行委员会管理。NBTRC 的 54 家参与医院分布在 27 个省/直辖市，每年进行超过 40000 例脑肿瘤手术。数据包括住院病历、图像和出院后的随访信息。数据可以通过三种方式上传：网络门户、远程物理服务器和离线软件。数据质量控制方案是七维的。每个参与医院都可以专注于单一的病理亚型和他们希望进行相关多中心临床研究的脑肿瘤公共亚型。基于利益共享机制的标准临床研究工作流程。数据收集将从 2019 年 2 月 1 日持续到 2024 年 1 月 31 日。
将获得所有参与者的知情同意。还将通过书面同意获得青少年参加的同意。研究结果将发表在专业期刊上，中英文双语。
中国临床试验注册中心（ChiCTR1900021096）。
