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)

May 29, 2020 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

99999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low-dose ASA cohort
A person is identified as newly exposed to low-dose ASA, he/she will become member of new user low-dose ASA cohort and that date will be the start date for outcome follow-up.
Drug: Acetylsalicylic Acid(BAYE4465, Aspirin )
Administration according to clinical practice
Comparison unexposed cohort
When a member of new user low-dose ASA cohort is confirmed, one comparison member will be confirmed also from the source population not yet censored on that day (start date) and with the same distribution of matching factors (age, sex, time interval since entry date and number of PCP visits in the year prior to start date) of its low-dose ASA pair with the only difference of being free of ASA on start date.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Age: 40-64 years, 65-74 years and 75 and more years.
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
Time Frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Sex: Male, Female
Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
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.
Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
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.
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
Time Frame: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
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
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).
Retrospective analysis between 1-Jan-2005 and 31-Dec-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2018

Primary Completion (ACTUAL)

April 15, 2019

Study Completion (ACTUAL)

May 31, 2019

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (ACTUAL)

November 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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