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Completed

NCT Number: 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

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.

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Key information

Conditions

Prevention of Oesophagus Cancer and Stomach Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetylsalicylic Acid(BAYE4465, Aspirin )

Drug

Administration according to clinical practice

Primary outcomes

  1. Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA overall compared to non-use

    Time frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

    Diagnosis of cancer is routinely recorded by means of Read codes in THIN database

  2. Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by age compared to non-use

    Time frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

    Age: 40-64 years, 65-74 years and 75 and more years.

  3. Incidence rates of oesophageal cancer and stomach cancer with use of low-dose ASA by sex-specific compared to non-use

    Time frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

    Sex: Male, Female

Secondary outcomes

  1. Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA

    Time frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

  2. Duration of low-dose ASA

    Time frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

    Duration of treatment will be calculated among current users.

  3. Dose-response of low-dose ASA

    Time frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

    The following daily doses will be ascertained: 75 mg, 150 mg and 300 mg.

  4. Number of case-fatality of oesophageal cancer and stomach cancer among new users of low-dose ASA

    Time frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

  5. Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA for primary or secondary cardiovascular prevention

    Time frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

    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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: ENgAGE-UK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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