Prevention of Oesophagus Cancer and Stomach CancerENgAGE-UKNCT03743883
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
An observational study of Prevention of Oesophagus Cancer and Stomach Cancer, run by Bayer at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Prevention of Oesophagus Cancer and Stomach Cancer
- What is being tested?
- Acetylsalicylic Acid(BAYE4465, Aspirin )
- How many people
- 99,999 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- To be exposed to low-dose ASA before entering in the study
- Having a diagnosis of any cancer before entering in the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Acetylsalicylic Acid(BAYE4465, Aspirin )
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid(BAYE4465, Aspirin )Drug
Administration according to clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Secondary outcomes (5)
Incidence of oesophageal cancer and stomach cancer among new users of low-dose ASA
Measured: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Duration of low-dose ASA
Duration of treatment will be calculated among current users.
Measured: 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.
Measured: 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
Measured: 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).
Measured: Retrospective analysis between 1-Jan-2005 and 31-Dec-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start30 Oct 2018
- Primary completion15 Apr 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Oesophagus Cancer and Stomach CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743883
- Sponsor's protocol ID
- 20326
- Acronym
- ENgAGE-UK
- Status last verified
- May 2020
- First submitted
- 14 Nov 2018
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03743883
- Acronym / sponsor ID
- ENgAGE-UK / 20326
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99,999 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose ASA cohort | – | Drug: Acetylsalicylic Acid(BAYE4465, Aspirin )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. |
| 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. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- To be exposed to low-dose ASA before entering in the study
- Having a diagnosis of any cancer before entering in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic Acid(BAYE4465, Aspirin )Administration according to clinical practice | Drug | Low-dose ASA cohort |
Primary outcome
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
5 secondary outcomes
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
Dose-response of low-dose ASA
Time 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Prevention of Oesophagus Cancer and Stomach Cancer
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Oesophagus Cancer and Stomach Cancer, run by Bayer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.