Colorectal NeoplasmsENgAGE-TaiwanNCT03579732
EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan
An observational study of Colorectal Neoplasms, run by Bayer at 1 site in Taiwan.
Trial summary
The study evaluates the protective effect of low-dose aspirin use on gastrointestinal cancers (colorectal, esophageal and gastric cancers) in long-term users, episodic users and non-users of aspirin in Taiwan. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Aspirin (Acetylsalicylic Acid, BAYE4465) and No drug
- How many people
- 4,710,504 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jun 2018to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from the Taiwanese National Health Insurance (NIH) database.
Who may be able to join
- Age 40 or older at the cohort entry date.
- Taiwanese National Health Insurance enrollees with non-missing and consistent age and gender information.
Who cannot join
- Subjects with any cancer diagnosis before cohort entry date.
- No use of National Health Insurance before the cohort entry date.
- Low dose aspirin prescription before cohort entry date.
- Subjects with conditions contra-indicated for low dose aspirin use before cohort entry date.
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates the protective effect of low-dose aspirin use on gastrointestinal cancers (colorectal, esophageal and gastric cancers) in long-term users, episodic users and non-users of aspirin in Taiwan.
Read the detailed description
The primary objective is to investigate the protective effect of long-term low dose use of aspirin on colorectal, esophageal and gastric cancer in adult subjects from Taiwan.
Secondary objectives are to evaluate the protective effect by duration of low-dose aspirin use on colorectal cancer, the effect of discontinuation of aspirin on colorectal cancer prevention, the staging distribution of colorectal cancer and the description of fatal cases due to colorectal cancer.
Aspirin use will be identified through Taiwanese National Health Insurance (NIH) data from 2000 to 2015. Cancer cases and staging of the three cancer types will be ascertained through the Taiwan Cancer Registry, using data from 2000 to 2014. Fatal cases will be ascertained using Mortality database from 2000 to 2015.
- Conditions
- Colorectal Neoplasms
- Being tested
- Aspirin (Acetylsalicylic Acid, BAYE4465), No drug
- Keywords
- Low-dose aspirin,, Cancer prevention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin (Acetylsalicylic Acid, BAYE4465)Drug
Low dose of aspirin, i.e. < 150 mg daily
No drugOther
Also called No aspirin
Non-consumers
| Study group | Role | What they receive |
|---|---|---|
| Long-term users | Adults using low-dose aspirin for > 3 years Receives: Drug: Aspirin (Acetylsalicylic Acid, BAYE4465) | |
| Episodic users | Adults using low-dose aspirin inconsistently, or consistently but < 3 years Receives: Drug: Aspirin (Acetylsalicylic Acid, BAYE4465) | |
| Former users | Subset of adult Episodic users of aspirin who discontinued the drug for at least 1 year before case/ control date Receives: Drug: Aspirin (Acetylsalicylic Acid, BAYE4465) | |
| Non-consumers | Adults who did not use low-dose aspirin Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with colorectal cancer
Number of subjects with colorectal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Measured: Up to 14 years
Number of subjects with esophageal cancer
Number of subjects with esophageal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Measured: Up to 14 years
Number of subjects with gastric cancer
Number of subjects with gastric cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Measured: Up to 14 years
Secondary outcomes (4)
Duration of aspirin use to colorectal cancer
The duration of low-dose aspirin use in years to colorectal cancer.
Measured: Up to 14 years
Time from aspirin discontinuation to colorectal cancer
Period of time in years from discontinuation of aspirin use to detection of colorectal cancer.
Measured: Up to 14 years
Stage of colorectal cancer
The stage of cancer will be determined according to the International Classification of Diseases for Oncology (ICD-O-3).
Measured: Up to 14 years
Number of fatal cases due to colorectal cancer
Derived from Taiwan Mortality database.
Measured: Up to 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start29 Jun 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 4,710,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579732
- Sponsor's protocol ID
- 19882
- Acronym
- ENgAGE-Taiwan
- Status last verified
- Sep 2020
- First submitted
- 26 Jun 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 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 - Taiwan
- ClinicalTrials.gov ID
- NCT03579732
- Acronym / sponsor ID
- ENgAGE-Taiwan / 19882
- Conditions
- Colorectal Neoplasms
- Keywords
- Low-dose aspirin,, Cancer prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,710,504 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 9 Jul 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.
The study evaluates the protective effect of low-dose aspirin use on gastrointestinal cancers (colorectal, esophageal and gastric cancers) in long-term users, episodic users and non-users of aspirin in Taiwan.
Detailed description
The primary objective is to investigate the protective effect of long-term low dose use of aspirin on colorectal, esophageal and gastric cancer in adult subjects from Taiwan.
Secondary objectives are to evaluate the protective effect by duration of low-dose aspirin use on colorectal cancer, the effect of discontinuation of aspirin on colorectal cancer prevention, the staging distribution of colorectal cancer and the description of fatal cases due to colorectal cancer.
Aspirin use will be identified through Taiwanese National Health Insurance (NIH) data from 2000 to 2015. Cancer cases and staging of the three cancer types will be ascertained through the Taiwan Cancer Registry, using data from 2000 to 2014. Fatal cases will be ascertained using Mortality database from 2000 to 2015.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Long-term users | – | Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)Adults using low-dose aspirin for > 3 years |
| Episodic users | – | Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)Adults using low-dose aspirin inconsistently, or consistently but < 3 years |
| Former users | – | Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)Subset of adult Episodic users of aspirin who discontinued the drug for at least 1 year before case/ control date |
| Non-consumers | – | Other: No drugAdults who did not use low-dose aspirin |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from the Taiwanese National Health Insurance (NIH) database.
Key inclusion criteria (2 listed)
- Age 40 or older at the cohort entry date.
- Taiwanese National Health Insurance enrollees with non-missing and consistent age and gender information.
Key exclusion criteria (4 listed)
- Subjects with any cancer diagnosis before cohort entry date.
- No use of National Health Insurance before the cohort entry date.
- Low dose aspirin prescription before cohort entry date.
- Subjects with conditions contra-indicated for low dose aspirin use before cohort entry date.
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 |
|---|---|---|
| Aspirin (Acetylsalicylic Acid, BAYE4465)Low dose of aspirin, i.e. < 150 mg daily | Drug | Episodic users, Former users, Long-term users |
| No drugAlso: No aspirinNon-consumers | Other | Non-consumers |
Primary outcome
Number of subjects with colorectal cancer
Time frame: Up to 14 years
Number of subjects with colorectal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Number of subjects with esophageal cancer
Time frame: Up to 14 years
Number of subjects with esophageal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Number of subjects with gastric cancer
Time frame: Up to 14 years
Number of subjects with gastric cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
4 secondary outcomes
Duration of aspirin use to colorectal cancer
Time frame: Up to 14 years
Time from aspirin discontinuation to colorectal cancer
Time frame: Up to 14 years
Stage of colorectal cancer
Time frame: Up to 14 years
Number of fatal cases due to colorectal cancer
Time frame: Up to 14 years
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 29 Sep 2020.
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 Colorectal Neoplasms, run by Bayer at 1 site in Taiwan.
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 2 inclusion and 4 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 29 Sep 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 Taiwan. 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?
Number of subjects with colorectal cancer (time frame: Up to 14 years). 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 29 Sep 2020.