Evaluating efficacy of screening for upper gastrointestinal cancer in China: a study protocol for a randomized controlled trial.
Evaluating efficacy of screening for upper gastrointestinal cancer in China: a study protocol for a randomized controlled trial.
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DOI：
10.21147/j.issn.1000-9604.2017.04.02
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发表时间：
2017-08
期刊：
影响因子：
--
通讯作者：
He J
中科院分区：
文献类型：
--
作者：
Chen W;Zeng H;Chen R;Xia R;Yang Z;Xia C;Zheng R;Wei W;Zhuang G;Yu X;He J
评价中国高危和非高危地区上消化道癌症筛查程序的有效性和可行性。代表中国三个经济地理区域（东、中、西部）的七个市县被选为筛查中心：其中三个位于高风险地区，四个位于非高风险地区。这七个中心的村庄/社区被视为集群，按每个中心分层1:1的比例随机分配到干预组（通过内窥镜检查筛查）或对照组（正常社区护理）。参赛对象为所选村/社区年龄在40-69岁、近3年内无癌症病史、无内镜检查史、身心健康的当地居民。不愿意接受内镜检查或不愿意签署知情同意书者被排除在研究之外。总共将报名140,000名参与者。在上消化道癌症高危地区，筛查组所有受试者均进行内镜筛查。在非高危地区，筛查组中30%的受试者将接受内镜筛查。 主要结局是上消化道癌症引起的死亡率。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其他数据，以回答有关筛查效果的重要问题。在那些有积极结果的领域评估的筛查策略可以在全国范围内推广并应用于大多数中国人。另一方面，负面结果将为放弃测试并将资源转移到其他地方提供科学证据。该研究已在中国临床试验注册中心方案注册系统注册（编号：ChiCTR-EOR-16008577）。
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).
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影响因子：
4.3
作者：
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通讯作者：
Hamashima, Chisato
DOI：
10.1016/j.bpg.2005.04.006
发表时间：
2005-12-01
期刊：
Best practice & research. Clinical gastroenterology
影响因子：
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作者：
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通讯作者：
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作者：
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作者：
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影响因子：
9.7
作者：
Chen, Wanqing;Zheng, Rongshou;He, Jie
通讯作者：
He, Jie