check_circleStudy Completed

Prevention of oesophagus cancer and stomach cancer

Bayer Identifier:

20326

ClinicalTrials.gov Identifier:

NCT03743883

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

All

Age

40 - 89 Years
  • - 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

  • - 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
99999
Trial Dates
October 2018 - May 2019
Phase
N/A
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, United Kingdom

Primary Outcome

  • 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
    date_rangeTime Frame:
    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-use
    Age: 40–64 years, 65–74 years and 75 and more years.
    date_rangeTime Frame:
    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-use
    Sex: Male, Female
    date_rangeTime Frame:
    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 ASA
    date_rangeTime Frame:
    Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
  • Duration of low-dose ASA
    Duration of treatment will be calculated among current users.
    date_rangeTime Frame:
    Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
  • Dose-response of low-dose ASA
    The following daily doses will be ascertained: 75 mg, 150 mg and 300 mg.
    date_rangeTime Frame:
    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 ASA
    date_rangeTime Frame:
    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 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).
    date_rangeTime Frame:
    Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

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
N/A

Additional Information

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