Prevention of Oesophagus Cancer and Stomach Cancer Clinical Trial
— ENgAGE-UKOfficial 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
| NCT number | NCT03743883 |
| Other study ID # | 20326 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 30, 2018 |
| Est. completion date | May 31, 2019 |
| Verified date | May 2020 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 99999 |
| Est. completion date | May 31, 2019 |
| Est. primary completion date | April 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 89 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Many locations | Multiple Locations |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA overall compared to non-use | Diagnosis of cancer is routinely recorded by means of Read codes in THIN database | Retrospective analysis between 1-Jan-2005 and 31-Dec-2017 | |
| Primary | Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by age compared to non-use | Age: 40-64 years, 65-74 years and 75 and more years. | Retrospective analysis between 1-Jan-2005 and 31-Dec-2017 | |
| Primary | Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by sex-specific compared to non-use | Sex: Male, Female | Retrospective analysis between 1-Jan-2005 and 31-Dec-2017 | |
| Secondary | Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA | Retrospective analysis between 1-Jan-2005 and 31-Dec-2017 | ||
| Secondary | Duration of low-dose ASA | Duration of treatment will be calculated among current users. | Retrospective analysis between 1-Jan-2005 and 31-Dec-2017 | |
| Secondary | Dose-response of low-dose ASA | The following daily doses will be ascertained: 75 mg, 150 mg and 300 mg. | Retrospective analysis between 1-Jan-2005 and 31-Dec-2017 | |
| Secondary | 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 | ||
| Secondary | Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA for primary or secondary cardiovascular prevention | 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). | Retrospective analysis between 1-Jan-2005 and 31-Dec-2017 |