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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 4710504

Contacts and Locations

Study Locations

• Taiwan
  • Taipeh, Taiwan, 100
    • National University of Taiwan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from the Taiwanese National Health Insurance (NIH) database.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

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 Names: No aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cancer prevention; Low-dose aspirin,
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Gastrointestinal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 19882

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No