EffectiveNess of Low-dose Aspirin in Prevention of Cancer in the Stomach and Oesophagus (GastrointEstinal Cancer Prevention) - United Kingdom ("ENgAGE - UK"): Study to Evaluate the Risk of Cancer in the Stomach and Oesophagus Among New Users of Low-dose Aspirin Using the THIN Database in the UK

Completed

• Conditions: Prevention of Oesophagus Cancer and Stomach Cancer
• Interventions: Drug: Acetylsalicylic Acid(BAYE4465, Aspirin )

• Registration Number: NCT03743883
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-10-30
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Primary Completion: 2019-04-15
• Study Completion: 2019-05-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99999

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-dose ASA cohort	Acetylsalicylic Acid(BAYE4465, Aspirin )	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.

Primary Outcome Measures

Name	Time	Method
Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by sex-specific compared to non-use	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	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	Retrospective analysis between 1-Jan-2005 and 31-Dec-2017	Age: 40-64 years, 65-74 years and 75 and more years.

Secondary Outcome Measures

Name	Time	Method
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	The following daily doses will be ascertained: 75 mg, 150 mg and 300 mg.
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	The primary and secondary cardiovascular prevention population of low-dose ASA users will be defined using a computer algorithm ascertaining any recorded Read code suggestive of cardiovascular disease (CVD).
Duration of low-dose ASA	Retrospective analysis between 1-Jan-2005 and 31-Dec-2017	Duration of treatment will be calculated among current users.
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

Trial Locations

Locations (1)

Many locations; 🇬🇧 Multiple Locations, United Kingdom