Baili Paolo, Torresani Michele, Agresti Roberto, Rosito Giuseppe, Daidone Maria Grazia, Veneroni Silvia, Cavallo Ilaria, Funaro Francesco, Giunco Marco, Turco Alberto, Amash Hade, Scavo Antonio, Minicozzi Pamela, Bella Francesca, Meneghini Elisabetta, Sant Milena
Analytic Epidemiology and Health Impact Unit, Fondazione IRCCS "Istituto Nazionale dei Tumori", Milan - Italy.
Tumori. 2015 Jul-Aug;101(4):440-6. doi: 10.5301/tj.5000341. Epub 2015 May 2.
In clinical research, many potentially useful variables are available via the routine activity of cancer center-based clinical registries (CCCR). We present the experience of the breast cancer clinical registry at Fondazione IRCCS "Istituto Nazionale dei Tumori" to give an example of how a CCCR can be planned, implemented, and used. Five criteria were taken into consideration while planning our CCCR: (a) available clinical and administrative databases ought to be exploited to the maximum extent; (b) open source software should be used; (c) a Web-based interface must be designed; (d) CCCR data must be compatible with population-based cancer registry data; (e) CCCR must be an open system, able to be connected with other data repositories. The amount of work needed for the implementation of a CCCR is inversely linked with the amount of available coded data: the fewer data are available in the input databases as coded variables, the more work will be necessary, for information technology staff, text mining analysis, and registrars (for collecting data from clinical records). A cancer registry in a comprehensive cancer center can be used for several research aspects, such as estimate of the number of cases needed for clinical studies, assessment of biobank specimens with specific characteristics, evaluation of clinical practice and adhesion to clinical guidelines, comparative studies between clinical and population sets of patients, studies on cancer prognosis, and studies on cancer survivorship.
在临床研究中，通过以癌症中心为基础的临床登记系统（CCCR）的日常活动可获取许多潜在有用的变量。我们介绍了意大利国家肿瘤研究所（Fondazione IRCCS "Istituto Nazionale dei Tumori"）乳腺癌临床登记系统的经验，以举例说明如何规划、实施和使用CCCR。在规划我们的CCCR时考虑了五个标准：（a）应最大限度地利用现有的临床和行政数据库；（b）应使用开源软件；（c）必须设计基于网络的界面；（d）CCCR数据必须与基于人群的癌症登记数据兼容；（e）CCCR必须是一个开放系统，能够与其他数据存储库连接。实施CCCR所需的工作量与可用编码数据量成反比：输入数据库中作为编码变量可用的数据越少，信息技术人员、文本挖掘分析人员和登记员（用于从临床记录中收集数据）所需的工作量就越大。综合癌症中心的癌症登记系统可用于多个研究方面，如估计临床研究所需的病例数、评估具有特定特征的生物样本库标本、评估临床实践和对临床指南的遵循情况、临床患者组与人群患者组之间的比较研究、癌症预后研究以及癌症生存研究。
