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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic Acid (Aspirin, BAYE4465) | Drug | Follow clinical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | Retrospective analysis between 1st January 2004 and 31st December 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of aspirin use | Minimum duration of aspirin use to confer the protective effects in preventing colorectal, gastric and esophageal cancer | Retrospective analysis between 1st January 2004 and 31st December 2008 |
| Risk of colorectal, gastric and esophageal cancer after discontinuation of aspirin use |
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Inclusion Criteria:
- Received prescription of either low-dose aspirin (75-300 mg) or paracetamol monotherapy during enrolment period.
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hong Kong | Hong Kong | Hong Kong |
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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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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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. |
| Retrospective analysis between 1st January 2004 and 31st December 2008 |
| Case-fatality and survival rate | For colorectal cancer, gastric or oesophageal | Retrospective analysis between 1st January 2004 and 31st December 2008 |
| D005767 |
| Gastrointestinal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |