Clinical trial NCT03743883: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevention of Oesophagus Cancer and Stomach Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 99999
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source population will be constituted (inclusion criteria) by individuals who are aged 40-89 years in the THIN database in the UK, who are enrolled with the primary care doctor (PCP) for at least 2 years, or have a history of computerized prescriptions for at least 1 year prior to start date and who are free of low-dose ASA and cancer to become a member of the source population.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA overall compared to non-use
timeFrame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
measure: Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by age compared to non-use
timeFrame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
measure: Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by sex-specific compared to non-use
timeFrame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Secondary outcomes:
measure: Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA
timeFrame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
measure: Duration of low-dose ASA
timeFrame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
measure: Dose-response of low-dose ASA
timeFrame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
measure: Number of case-fatality of oesophageal cancer and stomach cancer among new users of low-dose ASA
timeFrame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
measure: Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA for primary or secondary cardiovascular prevention
timeFrame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Other outcomes:
Locations:
city: Multiple Locations
country: United Kingdom
facility: Many locations
Study officials:
References: