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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)

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ClinicalTrials.gov Identifier: NCT03743883
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Prevention of Oesophagus Cancer and Stomach Cancer Drug: Acetylsalicylic Acid(BAYE4465, Aspirin )

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Study Type : Observational
Actual Enrollment : 99999 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Aspirin

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743883


Locations
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United Kingdom
Many locations
Multiple Locations, United Kingdom
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03743883     History of Changes
Other Study ID Numbers: 20326
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aspirin
Gastrointestinal Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics