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临床试验/NCT03743883
NCT03743883已完成不适用

Effectiveness of Low-dose Aspirin in Gastrointestinal Cancer Prevention -United Kingdom ("ENgAGE - UK"): A Cohort Study on the Risk of Gastric and Oesophageal Cancer Among New Users of Low-dose Aspirin Using the THIN Database in the UK

Bayer1 个研究点 分布在 1 个国家目标入组 99,999 人开始时间: 2018年10月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
99,999
试验地点
1
主要终点
Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by sex-specific compared to non-use

研究概览

简要总结

Researchers already did studies in low-dose Aspirin for the prevention of heart and blood vessels disease and for the prevention of cancer of the colorectum. In this study, they want to learn whether an effect for the prevention of oesophagus cancer and stomach cancer goes along with the use of low-dose ASA on patients taking this medicine for the prevention of heart and blood vessels disease compared to non-use. To find this out electronic medical records stored in primary care database in the UK, The Health Improvement Network (THIN), will be used.

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 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 40-89 years
  • Enrolled with the PCP for at least 2 years
  • To have a history of computerized prescriptions in THIN for at least 1 year prior to start date

排除标准

  • To be exposed to low-dose ASA before entering in the study
  • Having a diagnosis of any cancer before entering in the study

研究组 & 干预措施

Low-dose ASA cohort

A person is identified as newly exposed to low-dose ASA, he/she will become member of new user low-dose ASA cohort and that date will be the start date for outcome follow-up.

干预措施: Acetylsalicylic Acid(BAYE4465, Aspirin ) (Drug)

结局指标

主要结局

Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by sex-specific compared to non-use

时间窗: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

Sex: Male, Female

Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA overall compared to non-use

时间窗: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

Diagnosis of cancer is routinely recorded by means of Read codes in THIN database

Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by age compared to non-use

时间窗: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

Age: 40-64 years, 65-74 years and 75 and more years.

次要结局

  • Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA(Retrospective analysis between 1-Jan-2005 and 31-Dec-2017)
  • Dose-response of low-dose ASA(Retrospective analysis between 1-Jan-2005 and 31-Dec-2017)
  • Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA for primary or secondary cardiovascular prevention(Retrospective analysis between 1-Jan-2005 and 31-Dec-2017)
  • Duration of low-dose ASA(Retrospective analysis between 1-Jan-2005 and 31-Dec-2017)
  • Number of case-fatality of oesophageal cancer and stomach cancer among new users of low-dose ASA(Retrospective analysis between 1-Jan-2005 and 31-Dec-2017)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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