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可治愈性手术治疗非小细胞肺癌患者的结局和预后:一项真实世界、回顾性、基于人群和全国性的中国国家肺癌队列研究(CNLCC)方案。

Outcomes and prognosis of non-small cell lung cancer patients who underwent curable surgery: a protocol for a real-world, retrospective, population-based and nationwide Chinese National Lung Cancer Cohort (CNLCC) study.

机构信息

Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Chaoyang, China.

Department of Thoracic surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Chaoyang, China.

出版信息

BMJ Open. 2023 Jun 28;13(6):e070188. doi: 10.1136/bmjopen-2022-070188.

Abstract

INTRODUCTION

Surgery is one of the main approaches for the comprehensive treatment of early and locally advanced non-small cell lung cancer (NSCLC). This study conducts a nationwide multicentre study to explore factors that could influence the outcomes of patients with I-IIIA NSCLC who underwent curable surgery in real-world scenarios.

METHODS AND ANALYSIS

All patients diagnosed with NSCLC between January 2013 and December 2020 will be identified from 30 large public medical services centres in mainland China. The algorithm of natural language processing and artificial intelligence techniques were used to extract data from electronic health records of enrolled patients who fulfil the inclusion criteria. Six categories of parameters are collected and stored from the electronic records, then the parameters will be structured as a high-quality structured case report form. The code book will be compiled and each parameter will be classified and designated a code. In addition, the study retrieves the survival status and causes of death of patients from the Chinese Centre for Disease Control and Prevention. The primary endpoints are overall survival and the secondary endpoint is disease-free survival. Finally, an online platform is formed for data queries and the original records will be stored as secure electronic documents.

ETHICS AND DISSEMINATION

The study has been approved by the Ethical Committee of the Chinese Academy of Medical Sciences. Study findings will be disseminated via presentations at conferences and publications in open-access journals. This study has been registered in the Chinese Trial Register (ChiCTR2100052773) on 11 May 2021, http://www.chictr.org.cn/showproj.aspx?proj=136659.

TRIAL REGISTRATION NUMBER

ChiCTR2100052773.

摘要

简介

手术是综合治疗早期和局部晚期非小细胞肺癌(NSCLC)的主要方法之一。本研究通过一项全国多中心研究,旨在探讨真实世界中可切除的 I-IIIA 期 NSCLC 患者的治疗结果的影响因素。

方法与分析

将从中国大陆 30 家大型公立医疗服务中心中筛选出 2013 年 1 月至 2020 年 12 月期间被诊断为 NSCLC 的所有患者。将使用自然语言处理和人工智能技术算法从符合纳入标准的患者电子病历中提取数据。将从电子记录中收集和存储六类参数,并将参数结构化成为高质量的病例报告表。将编写代码簿,并对每个参数进行分类和指定代码。此外,本研究还将从中国疾病预防控制中心检索患者的生存状态和死亡原因。主要终点为总生存期,次要终点为无病生存期。最后,将形成一个在线平台以进行数据查询,并将原始记录存储为安全的电子文件。

伦理与传播

本研究已获得中国医学科学院伦理委员会的批准。研究结果将通过会议报告和开放获取期刊发表进行传播。本研究已于 2021 年 5 月 11 日在中国临床试验注册中心(ChiCTR2100052773)注册,网址为:http://www.chictr.org.cn/showproj.aspx?proj=136659。

临床试验注册号

ChiCTR2100052773。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77d6/10410851/c8c67f60192f/bmjopen-2022-070188f01.jpg

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