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EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan (ENgAGE-Taiwan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579732
Recruitment Status : Completed
First Posted : July 9, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment
Colorectal Neoplasms Drug: Aspirin (Acetylsalicylic Acid, BAYE4465) Other: No drug

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.


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Study Type : Observational
Actual Enrollment : 4710504 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan
Actual Study Start Date : June 29, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
Long-term users
Adults using low-dose aspirin for > 3 years
Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)
Low dose of aspirin, i.e. < 150 mg daily

Episodic users
Adults using low-dose aspirin inconsistently, or consistently but < 3 years
Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)
Low dose of aspirin, i.e. < 150 mg daily

Former users
Subset of adult Episodic users of aspirin who discontinued the drug for at least 1 year before case/ control date
Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)
Low dose of aspirin, i.e. < 150 mg daily

Non-consumers
Adults who did not use low-dose aspirin
Other: No drug
Non-consumers
Other Name: No aspirin




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Duration of aspirin use to colorectal cancer [ Time Frame: Up to 14 years ]
    The duration of low-dose aspirin use in years to colorectal cancer.

  2. Time from aspirin discontinuation to colorectal cancer [ Time Frame: Up to 14 years ]
    Period of time in years from discontinuation of aspirin use to detection of colorectal cancer.

  3. Stage of colorectal cancer [ Time Frame: Up to 14 years ]
    The stage of cancer will be determined according to the International Classification of Diseases for Oncology (ICD-O-3).

  4. Number of fatal cases due to colorectal cancer [ Time Frame: Up to 14 years ]
    Derived from Taiwan Mortality database.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from the Taiwanese National Health Insurance (NIH) database.
Criteria

Inclusion Criteria:

  • Age 40 or older at the cohort entry date.
  • Taiwanese National Health Insurance enrollees with non-missing and consistent age and gender information.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579732


Locations
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Taiwan
National University of Taiwan Hospital
Taipeh, Taiwan, 100
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03579732     History of Changes
Other Study ID Numbers: 19882
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Low-dose aspirin,
Cancer prevention
Additional relevant MeSH terms:
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Colorectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics