EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Other: No drug; Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)

• Registration Number: NCT03579732
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study Start: 2018-06-29
• Study First Posted: 2018-07-09
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-27
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4710504

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-consumers	No drug	Adults who did not use low-dose aspirin
Episodic users	Aspirin (Acetylsalicylic Acid, BAYE4465)	Adults using low-dose aspirin inconsistently, or consistently but \< 3 years
Long-term users	Aspirin (Acetylsalicylic Acid, BAYE4465)	Adults using low-dose aspirin for \> 3 years
Former users	Aspirin (Acetylsalicylic Acid, BAYE4465)	Subset of adult Episodic users of aspirin who discontinued the drug for at least 1 year before case/ control date

Primary Outcome Measures

Name	Time	Method
Number of subjects with gastric cancer	Up to 14 years	Number of subjects with gastric cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Number of subjects with colorectal cancer	Up to 14 years	Number of subjects with colorectal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).
Number of subjects with esophageal cancer	Up to 14 years	Number of subjects with esophageal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).

Secondary Outcome Measures

Name	Time	Method
Stage of colorectal cancer	Up to 14 years	The stage of cancer will be determined according to the International Classification of Diseases for Oncology (ICD-O-3).
Duration of aspirin use to colorectal cancer	Up to 14 years	The duration of low-dose aspirin use in years to colorectal cancer.
Time from aspirin discontinuation to colorectal cancer	Up to 14 years	Period of time in years from discontinuation of aspirin use to detection of colorectal cancer.
Number of fatal cases due to colorectal cancer	Up to 14 years	Derived from Taiwan Mortality database.

Trial Locations

Locations (1)

National University of Taiwan Hospital; 🇨🇳 Taipeh, Taiwan