Gastrointestinal CancerENgAGE-HKNCT04081831
Effectiveness of Low Dose Aspirin in Decreasing the Chance Getting Stomach and Intestine Cancer
An observational study of Gastrointestinal Cancer, run by Bayer at 1 site in Hong Kong.
Trial summary
In this study, researchers wanted to learn more about the effect of Aspirin taken as low dose (75 - 300 mg) in preventing stomach, colorectal and esophagus cancer. The researchers were interested in the effect by duration of aspirin use and the effect on the time since aspirin intake has been stopped in preventing… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Acetylsalicylic Acid (Aspirin, BAYE4465)
- How many people
- 99,999 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jul 2019to 25 Aug 2020
- 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: Patients aged ≥ 40 years who received low dose aspirin (75-300 mg) or paracetamol between 1st January 2004 and 31st December 2008 will be identified from CDARS (Clinical Data Analysis and Reporting System). CDARS is an electronic clinical database which is managed by the Hospital Authority (HA). More than seven million Hong Kong citizens have access to public healthcare services provided by HA.
Who may be able to join
- Received prescription of either low-dose aspirin (75-300 mg) or paracetamol monotherapy during enrolment period.
Who cannot join
- Received prescription of aspirin monotherapy or combination one year prior to the index date
- Recorded diagnoses of any type of cancer before the index date
- Recorded procedures of colectomy, gastrectomy prior to the index date
- Age < 40 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Low-dose Aspirin in Gastrointestinal Cancer Prevention - Hong Kong
In this study, researchers wanted to learn more about the effect of Aspirin taken as low dose (75 - 300 mg) in preventing stomach, colorectal and esophagus cancer. The researchers were interested in the effect by duration of aspirin use and the effect on the time since aspirin intake has been stopped in preventing stomach, colorectal and esophagus cancer. In addition, the study also looked into the time patients survived after being diagnosed (survival rate) with cancer and number of cancer patients who died (case fatality rate). The study was based on an electronic database managed by the Health Authority in Hong Kong containing anonymized clinical information of patients living in Hong Kong.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Acetylsalicylic Acid (Aspirin, BAYE4465)
- Keywords
- Esophageal cancer, Gastric cancer, Colorectal cancer
- Medical subject headings
- Gastrointestinal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid (Aspirin, BAYE4465)Drug
Follow clinical administration
| Study group | Role | What they receive |
|---|---|---|
| New-users of Low-dose aspirin (exposed group) | New-users of low-dose aspirin is defined as patients who did not receive any prescriptions of low-dose aspirin one year prior to the index date. Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) | |
| Users of Paracetamol (non-exposed group) | Users of Paracetamol is defined as patients who receive first prescription of paracetamol during the study period. Since the patients receiving low-dose aspirin are potentially less healthy compared to non-users of aspirin, patients receiving paracetamol as the control group can minimise healthy user bias. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate ratio of colorectal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Measured: Retrospective analysis between 1st January 2004 and 31st December 2008
Incidence rate ratio of gastric cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Measured: Retrospective analysis between 1st January 2004 and 31st December 2008
Incidence rate ratio of esophageal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Measured: Retrospective analysis between 1st January 2004 and 31st December 2008
Secondary outcomes (3)
Duration of aspirin use
Minimum duration of aspirin use to confer the protective effects in preventing colorectal, gastric and esophageal cancer
Measured: Retrospective analysis between 1st January 2004 and 31st December 2008
Risk of colorectal, gastric and esophageal cancer after discontinuation of aspirin use
Logistic regression will be conducted based on nested case-control study with stratification on the recency of exposure with current use, past use, and distant use of aspirin.
Measured: Retrospective analysis between 1st January 2004 and 31st December 2008
Case-fatality and survival rate
For colorectal cancer, gastric or oesophageal
Measured: Retrospective analysis between 1st January 2004 and 31st December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start31 Jul 2019
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal 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
- NCT04081831
- Sponsor's protocol ID
- 20319
- Acronym
- ENgAGE-HK
- Status last verified
- Apr 2022
- First submitted
- 30 Jul 2019
- Last updated
- 19 Apr 2022
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low-dose Aspirin in Gastrointestinal Cancer Prevention - Hong Kong
- ClinicalTrials.gov ID
- NCT04081831
- Acronym / sponsor ID
- ENgAGE-HK / 20319
- Conditions
- Gastrointestinal Cancer
- Keywords
- Esophageal cancer, Gastric cancer, Colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99,999 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 9 Sep 2019 (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.
In this study, researchers wanted to learn more about the effect of Aspirin taken as low dose (75 - 300 mg) in preventing stomach, colorectal and esophagus cancer. The researchers were interested in the effect by duration of aspirin use and the effect on the time since aspirin intake has been stopped in preventing stomach, colorectal and esophagus cancer. In addition, the study also looked into the time patients survived after being diagnosed (survival rate) with cancer and number of cancer patients who died (case fatality rate). The study was based on an electronic database managed by the Health Authority in Hong Kong containing anonymized clinical information of patients living in Hong Kong.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New-users of Low-dose aspirin (exposed group) | – | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)New-users of low-dose aspirin is defined as patients who did not receive any prescriptions of low-dose aspirin one year prior to the index date. |
| Users of Paracetamol (non-exposed group) | – | –Users of Paracetamol is defined as patients who receive first prescription of paracetamol during the study period. Since the patients receiving low-dose aspirin are potentially less healthy compared to non-users of aspirin, patients receiving paracetamol as the control group can minimise healthy user bias. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 40 years who received low dose aspirin (75-300 mg) or paracetamol between 1st January 2004 and 31st December 2008 will be identified from CDARS (Clinical Data Analysis and Reporting System). CDARS is an electronic clinical database which is managed by the Hospital Authority (HA). More than seven million Hong Kong citizens have access to public healthcare services provided by HA.
Key inclusion criteria (1 listed)
- Received prescription of either low-dose aspirin (75-300 mg) or paracetamol monotherapy during enrolment period.
Key exclusion criteria (4 listed)
- Received prescription of aspirin monotherapy or combination one year prior to the index date
- Recorded diagnoses of any type of cancer before the index date
- Recorded procedures of colectomy, gastrectomy prior to the index date
- Age < 40 years
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 (Aspirin, BAYE4465)Follow clinical administration | Drug | New-users of Low-dose aspirin (exposed group) |
Primary outcome
Incidence rate ratio of colorectal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008
Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Incidence rate ratio of gastric cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008
Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Incidence rate ratio of esophageal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008
Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)
3 secondary outcomes
Duration of aspirin use
Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008
Risk of colorectal, gastric and esophageal cancer after discontinuation of aspirin use
Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008
Case-fatality and survival rate
Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008
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 19 Apr 2022.
- 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.
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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 Gastrointestinal Cancer, run by Bayer at 1 site in Hong Kong.
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 1 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 19 Apr 2022. 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 Hong Kong. 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 rate ratio of colorectal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed) (time frame: Retrospective analysis between 1st January 2004 and 31st December 2008). 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 19 Apr 2022.