Chen Wanqing, Zeng Hongmei, Chen Ru, Xia Ruyi, Yang Zhixun, Xia Changfa, Zheng Rongshou, Wei Wenqiang, Zhuang Guihua, Yu Xueqin, He Jie
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.
Chin J Cancer Res. 2017 Aug;29(4):294-302. doi: 10.21147/j.issn.1000-9604.2017.04.02.
To evaluate the efficacy and feasibility of screening procedure for upper gastrointestinal cancer in both high-risk and non-high-risk areas in China.
Seven cities/counties, representing three economical-geographical regions (Eastern, Central and Western) in China, were selected as screening centers: three in high-risk areas and four in non-high-risk areas.
Villages/communities in these seven centers regarded as clusters were randomly assigned to either intervention group (screening by endoscopic examination) or control group (with normal community care) in a 1:1 ratio stratified by each center. Eligible participants are local residents aged 40-69 years in the selected villages/communities with no history of cancer or endoscopic examination in the latest 3 years who are mentally and physically competent. Those who are not willing to take endoscopic examination or are unwilling to sign the consent form are excluded from the study. Totally 140,000 participants will be enrolled.
In high-risk areas of upper gastrointestinal cancer, all subjects in screening group will be screened by endoscopy. In non-high-risk areas, 30% of the subjects in screening group, identified through a survey, will be screened by endoscopy.
The primary outcome is the mortality caused by upper gastrointestinal cancer. The secondary outcomes include detection rate, incidence rate, survival rate, and clinical stage distribution. Additional data on quality of life and cost-effectiveness will also be collected to answer important questions regarding screening effects.
Screening strategy evaluated in those areas with positive findings may be promoted nationally and applied to the majority of Chinese people. On the other hand, negative findings will provide scientific evidence for abandoning a test and shifting resources elsewhere.
The study has been registered with the Protocol Registration System in Chinese Clinical Trial Registry (identifier: ChiCTR-EOR-16008577).
评估中国高危和非高危地区上消化道癌筛查程序的有效性和可行性。
选取代表中国三个经济地理区域（东部、中部和西部）的七个市/县作为筛查中心：三个在高危地区，四个在非高危地区。
这七个中心的村庄/社区被视为群组，按每个中心分层，以1:1的比例随机分配到干预组（通过内镜检查进行筛查）或对照组（接受常规社区护理）。符合条件的参与者是所选村庄/社区中年龄在40 - 69岁之间、最近3年内无癌症病史或内镜检查史且身心健康的当地居民。那些不愿意接受内镜检查或不愿意签署知情同意书的人被排除在研究之外。共招募140,000名参与者。
在上消化道癌高危地区，筛查组的所有受试者将接受内镜检查。在非高危地区，通过调查确定的筛查组中30%的受试者将接受内镜检查。
主要结局是上消化道癌导致的死亡率。次要结局包括检出率、发病率、生存率和临床分期分布。还将收集有关生活质量和成本效益的额外数据，以回答有关筛查效果的重要问题。
在这些地区评估的筛查策略若有阳性结果，可能会在全国推广并应用于大多数中国人。另一方面，阴性结果将为放弃一项检测并将资源转移到其他地方提供科学依据。
该研究已在中国临床试验注册中心的方案注册系统注册（标识符：ChiCTR-EOR-16008577）。
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