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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term users | Adults using low-dose aspirin for > 3 years |
| |
| Episodic users | Adults using low-dose aspirin inconsistently, or consistently but < 3 years |
| |
| Former users | Subset of adult Episodic users of aspirin who discontinued the drug for at least 1 year before case/ control date |
| |
| Non-consumers | Adults who did not use low-dose aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin (Acetylsalicylic Acid, BAYE4465) | Drug | Low dose of aspirin, i.e. < 150 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Up to 14 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of aspirin use to colorectal cancer | The duration of low-dose aspirin use in years to colorectal cancer. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be selected from the Taiwanese National Health Insurance (NIH) database.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Taiwan Hospital | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| C488176 | N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| No drug | Other | Non-consumers |
|
|
| 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). | Up to 14 years |
| Number of fatal cases due to colorectal cancer | Derived from Taiwan Mortality database. | Up to 14 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |