EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan

NCT ID: NCT03579732

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4710504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-29

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Long-term users

Adults using low-dose aspirin for \> 3 years

Aspirin (Acetylsalicylic Acid, BAYE4465)

Intervention Type DRUG

Low dose of aspirin, i.e. \< 150 mg daily

Episodic users

Adults using low-dose aspirin inconsistently, or consistently but \< 3 years

Aspirin (Acetylsalicylic Acid, BAYE4465)

Intervention Type DRUG

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

Aspirin (Acetylsalicylic Acid, BAYE4465)

Intervention Type DRUG

Low dose of aspirin, i.e. \< 150 mg daily

Non-consumers

Adults who did not use low-dose aspirin

No drug

Intervention Type OTHER

Non-consumers

Interventions

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Aspirin (Acetylsalicylic Acid, BAYE4465)

Low dose of aspirin, i.e. \< 150 mg daily

Intervention Type DRUG

No drug

Non-consumers

Intervention Type OTHER

Other Intervention Names

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No aspirin

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National University of Taiwan Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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19882

Identifier Type: -

Identifier Source: org_study_id

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