Lee Sangwon, Choi Yeon Ho, Kim Hak Min, Hong Min Ah, Park Phillip, Kwak In Hae, Kang Ye Ji, Choi Kui Son, Kong Hyun-Joo, Cha Hyosung, Kim Hyun-Jin, Ryu Kwang Sun, Jeon Young Sang, Kim Hwanhee, Jung Jip Min, Im Jeong-Soo, Chae Heejung
National Cancer Control Institute, National Cancer Center, Goyang, Korea.
Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea.
Cancer Res Treat. 2025 Jan;57(1):19-27. doi: 10.4143/crt.2024.218. Epub 2024 Jul 15.
The common data model (CDM) has found widespread application in healthcare studies, but its utilization in cancer research has been limited. This article describes the development and implementation strategy for Cancer Clinical Library Databases (CCLDs), which are standardized cancer-specific databases established under the Korea-Clinical Data Utilization Network for Research Excellence (K-CURE) project by the Korean Ministry of Health and Welfare. Fifteen leading hospitals and fourteen academic associations in Korea are engaged in constructing CCLDs for 10 primary cancer types. For each cancer type-specific CCLD, cancer data experts determine key clinical data items essential for cancer research, standardize these items across cancer types, and create a standardized schema. Comprehensive clinical records covering diagnosis, treatment, and outcomes, with annual updates, are collected for each cancer patient in the target population, and quality control is based on six-sigma standards. To protect patient privacy, CCLDs follow stringent data security guidelines by pseudonymizing personal identification information and operating within a closed analysis environment. Researchers can apply for access to CCLD data through the K-CURE portal, which is subject to Institutional Review Board and Data Review Board approval. The CCLD is considered a pioneering standardized cancer-specific database, significantly representing Korea's cancer data. It is expected to overcome limitations of previous CDMs and provide a valuable resource for multicenter cancer research in Korea.
通用数据模型(CDM)已在医疗保健研究中得到广泛应用,但其在癌症研究中的应用一直有限。本文介绍了癌症临床图书馆数据库(CCLD)的开发和实施策略,这些数据库是韩国卫生与福利部在卓越研究韩国临床数据利用网络(K-CURE)项目下建立的标准化癌症特定数据库。韩国的15家领先医院和14个学术协会正在为10种原发性癌症类型构建CCLD。对于每种特定癌症类型的CCLD,癌症数据专家确定癌症研究所需的关键临床数据项,对这些数据项在不同癌症类型间进行标准化,并创建标准化架构。针对目标人群中的每位癌症患者收集涵盖诊断、治疗和结果的全面临床记录,并每年更新,质量控制基于六西格玛标准。为保护患者隐私,CCLD通过对个人身份信息进行假名化处理并在封闭的分析环境中运行,遵循严格的数据安全准则。研究人员可通过K-CURE门户网站申请访问CCLD数据,该申请需经机构审查委员会和数据审查委员会批准。CCLD被视为一个开创性的标准化癌症特定数据库,显著代表了韩国的癌症数据。预计它将克服先前CDM的局限性,并为韩国的多中心癌症研究提供宝贵资源。