Skip to main content
OpenTrials
Completed

NCT Number: NCT03579732

EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National University of Taiwan Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin (Acetylsalicylic Acid, BAYE4465)

Drug

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

No drug

Other

Non-consumers

Other names: No aspirin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: ENgAGE-Taiwan

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2018
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.