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中国高危人群食管癌前瞻性队列研究-食管癌及癌前病变的全国队列研究(NCEC-HRP):研究方案。

The National Cohort of Esophageal Cancer-Prospective Cohort Study of Esophageal Cancer and Precancerous Lesions based on High-Risk Population in China (NCEC-HRP): study protocol.

机构信息

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

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

出版信息

BMJ Open. 2019 Apr 3;9(4):e027360. doi: 10.1136/bmjopen-2018-027360.

DOI:10.1136/bmjopen-2018-027360
PMID:30948615
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6500261/
Abstract

INTRODUCTION

Oesophageal cancer (OC) is one of the most common cancers worldwide and about 50% of all new cases occurred in China. Population-based screening has been conducted in high-risk areas in China since 1970s, however, a few factors have limited the integration of the results from previous studies and the sharing of existing resources, such as the difference in screening methods and protocols, inconsistencies in questionnaires for risk factors investigation, lack of standards for sample collection and incomplete follow-up information.

METHODS AND ANALYSIS

The National Cohort of Esophageal Cancer-Prospective Cohort Study of Esophageal Cancer and Precancerous Lesions based on High-Risk Population (NCEC-HRP) is a prospective cohort study of OC screening based on high-risk population in China supported by the National Key R&D Programme. Eight areas located at eastern, central and western China are selected as screening centres to represent three economical-geographical regions. All local residents aged 40-69 years in the selected areas are invited to take endoscopic examination and risk factors investigation unless they meet the exclusion criteria. The recruitment began on June 2017 and a total of 100 000 participants will be enrolled by December 2020 and all subjects will be followed for a long time. This study is designed as open-ended and has broad research aims. Summary statistics for baseline information will be reported after the completion of recruitment. We will develop a series of standards and guidelines for OC screening during the study. An open and shared research platform linked with epidemiological databases and biobank will be built up for further research.

ETHICS AND DISSEMINATION

The study is approved by the Ethics Committee of Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (approval number 16-171/1250). The findings of the study will be disseminated through scientific peer-reviewed journals as well as the public via the study website (http://www.ncec-china.cn).

TRIAL REGISTRATION NUMBER

ChiCTR-EOC-17010553; Pre-results.

摘要

简介

食管癌(OC)是全球最常见的癌症之一,约 50%的新发病例发生在中国。自 20 世纪 70 年代以来,中国已在高危地区开展人群筛查,但一些因素限制了以往研究结果的整合和现有资源的共享,例如筛查方法和方案的差异、危险因素调查问卷的不一致、样本采集标准缺乏以及随访信息不完整。

方法和分析

国家癌症中心食管癌前瞻性队列研究——基于高危人群的食管癌及癌前病变研究(NCEC-HRP)是一项由国家重点研发计划支持的基于中国高危人群的 OC 筛查的前瞻性队列研究。选择中国东部、中部和西部地区的 8 个地区作为筛查中心,以代表三个经济地理区域。所有符合条件的 40-69 岁当地居民均被邀请接受内镜检查和危险因素调查,除非他们符合排除标准。招募工作于 2017 年 6 月开始,计划到 2020 年 12 月共招募 10 万名参与者,并对所有受试者进行长期随访。本研究为开放式设计,具有广泛的研究目标。在招募完成后,将报告基线信息的汇总统计数据。我们将在研究过程中制定一系列 OC 筛查标准和指南。还将建立一个与流行病学数据库和生物库链接的开放共享研究平台,以进行进一步的研究。

伦理和传播

该研究已获得中国医学科学院北京协和医学院肿瘤医院伦理委员会的批准(批准号:16-171/1250)。研究结果将通过科学同行评议期刊以及研究网站(http://www.ncec-china.cn)向公众传播。

临床试验注册编号

ChiCTR-EOC-17010553;预注册结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4641/6500261/20242f60778f/bmjopen-2018-027360f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4641/6500261/6f00e2398773/bmjopen-2018-027360f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4641/6500261/20242f60778f/bmjopen-2018-027360f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4641/6500261/6f00e2398773/bmjopen-2018-027360f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4641/6500261/20242f60778f/bmjopen-2018-027360f02.jpg

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