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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03743883
Acronym
ENgAGE-UK
Enrollment
99999
Registered
2018-11-16
Start date
2018-10-30
Completion date
2019-05-31
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Oesophagus Cancer and Stomach Cancer

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.

Interventions

DRUGAcetylsalicylic Acid(BAYE4465, Aspirin )

Administration according to clinical practice

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA overall compared to non-useRetrospective analysis between 1-Jan-2005 and 31-Dec-2017Diagnosis 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-useRetrospective analysis between 1-Jan-2005 and 31-Dec-2017Age: 40-64 years, 65-74 years and 75 and more years.
Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by sex-specific compared to non-useRetrospective analysis between 1-Jan-2005 and 31-Dec-2017Sex: Male, Female

Secondary

MeasureTime frameDescription
Number of case-fatality of oesophageal cancer and stomach cancer among new users of low-dose ASARetrospective analysis between 1-Jan-2005 and 31-Dec-2017
Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASARetrospective 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 preventionRetrospective analysis between 1-Jan-2005 and 31-Dec-2017The 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 ASARetrospective analysis between 1-Jan-2005 and 31-Dec-2017Duration of treatment will be calculated among current users.
Dose-response of low-dose ASARetrospective analysis between 1-Jan-2005 and 31-Dec-2017The following daily doses will be ascertained: 75 mg, 150 mg and 300 mg.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026