Trial Condition(s):
Prevention of oesophagus cancer and stomach cancer
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 (ENgAGE–UK)
Bayer Identifier:
20326
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA overall compared to non-useDiagnosis of cancer is routinely recorded by means of Read codes in THIN databaseTimeframe: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
- Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by age compared to non-useAge: 40–64 years, 65–74 years and 75 and more years.Timeframe: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
- Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by sex-specific compared to non-useSex: Male, FemaleTimeframe: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Secondary Outcome
- Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASATimeframe: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
- Duration of low-dose ASADuration of treatment will be calculated among current users.Timeframe: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
- Dose-response of low-dose ASAThe following daily doses will be ascertained: 75 mg, 150 mg and 300 mg.Timeframe: 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 ASATimeframe: 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 preventionThe 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).Timeframe: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Additional Information
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