EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 4,710,504
- 试验地点
- 1
- 主要终点
- Number of subjects with gastric cancer
研究概览
简要总结
The study evaluates the protective effect of low-dose aspirin use on gastrointestinal cancers (colorectal, esophageal and gastric cancers) in long-term users, episodic users and non-users of aspirin in Taiwan.
详细描述
The primary objective is to investigate the protective effect of long-term low dose use of aspirin on colorectal, esophageal and gastric cancer in adult subjects from Taiwan.
Secondary objectives are to evaluate the protective effect by duration of low-dose aspirin use on colorectal cancer, the effect of discontinuation of aspirin on colorectal cancer prevention, the staging distribution of colorectal cancer and the description of fatal cases due to colorectal cancer.
Aspirin use will be identified through Taiwanese National Health Insurance (NIH) data from 2000 to 2015. Cancer cases and staging of the three cancer types will be ascertained through the Taiwan Cancer Registry, using data from 2000 to 2014. Fatal cases will be ascertained using Mortality database from 2000 to 2015.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 or older at the cohort entry date.
- •Taiwanese National Health Insurance enrollees with non-missing and consistent age and gender information.
排除标准
- •Subjects with any cancer diagnosis before cohort entry date.
- •No use of National Health Insurance before the cohort entry date.
- •Low dose aspirin prescription before cohort entry date.
- •Subjects with conditions contra-indicated for low dose aspirin use before cohort entry date.
研究组 & 干预措施
Long-term users
Adults using low-dose aspirin for > 3 years
干预措施: Aspirin (Acetylsalicylic Acid, BAYE4465) (Drug)
Episodic users
Adults using low-dose aspirin inconsistently, or consistently but < 3 years
干预措施: Aspirin (Acetylsalicylic Acid, BAYE4465) (Drug)
Former users
Subset of adult Episodic users of aspirin who discontinued the drug for at least 1 year before case/ control date
干预措施: Aspirin (Acetylsalicylic Acid, BAYE4465) (Drug)
Non-consumers
Adults who did not use low-dose aspirin
干预措施: No drug (Other)
结局指标
主要结局
Number of subjects with gastric cancer
时间窗: Up to 14 years
Number of subjects with gastric cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Number of subjects with colorectal cancer
时间窗: Up to 14 years
Number of subjects with colorectal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Number of subjects with esophageal cancer
时间窗: Up to 14 years
Number of subjects with esophageal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
次要结局
- Stage of colorectal cancer(Up to 14 years)
- Duration of aspirin use to colorectal cancer(Up to 14 years)
- Time from aspirin discontinuation to colorectal cancer(Up to 14 years)
- Number of fatal cases due to colorectal cancer(Up to 14 years)