Effect of Endoscopic Screening on Esophageal Cancer Incidence and Mortality: 10-year Follow up of a Community-based, Controlled Study Among High Risk Population in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45,386
- 试验地点
- 1
- 主要终点
- incidence and mortality of ESCC
研究概览
简要总结
Importance: There are no global screening recommendations for esophageal squamous cell carcinoma (ESCC). Endoscopic screening has been investigated in high incidence areas of China since 1970's. But up until now there no apparent evidence that would lead to a reduction in disease morbidity and mortality.
Objective: To evaluate whether endoscopic screening and early intervention program could reduce the incidence or mortality of ESCC.
Design: Community-based, controlled cohort study among 45 386 residents, Endoscopy screening was completed from November 1999 to May of 2000. Subjects in intervention group were examined once during intervention period. The study follow-up concluded in December 2009.
Setting: High risk area of ESCC in China
Participants:Cluster sampling from communities with high rates of esophageal cancer. A set of villages with was selected as the study intervention community. Age 40 to 69 years residents were selected as an eligible population. Another set of villages was select as the control population. Buffer villages were set up between intervention and control group.
Intervention: Endoscopy with Lugol's iodine staining and early treatment on precancerous lesions was undergone for the intervention group.
Main Outcome(s) and Measure(s): Incidence and mortality ESCC
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •local residents
- •Men and women aged 40 to 69 years
- •no contraindications for endoscopic examinations (e.g. history of reaction of iodine or lidocaine), and who were mentally and physically competent to provide written informed consent.
- •informed consent
排除标准
- •Not local residents
- •age younger than 40 yrs and older than 69 yrs
- •History of reaction of iodine or lidocaine
- •contraindications for endoscopic examinations
结局指标
主要结局
incidence and mortality of ESCC
时间窗: 10 years
次要结局
- Cumulative incidence and mortality of total cancer, and gastric cardia cancer(10 years)
研究者
Youlin Qiao
Professor and Director of Department of Cancer Epidemiology
Chinese Academy of Medical Sciences