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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 : Active, not recruiting
First Posted : November 16, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date November 14, 2018
First Posted Date November 16, 2018
Last Update Posted Date April 18, 2019
Actual Study Start Date October 30, 2018
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2018)
  • 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
  • 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.
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03743883 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 14, 2018)
  • 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 ]
  • 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.
  • 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.
  • 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 ]
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Prevention of Oesophagus Cancer and Stomach Cancer
Intervention Drug: Acetylsalicylic Acid(BAYE4465, Aspirin )
Administration according to clinical practice
Study Groups/Cohorts
  • 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.
    Intervention: Drug: Acetylsalicylic Acid(BAYE4465, Aspirin )
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 14, 2018)
500000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2019
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03743883
Other Study ID Numbers 20326
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators Not Provided
PRS Account Bayer
Verification Date April 2019