EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan

Colorectal Neoplasms Clinical Trial

— ENgAGE-Taiwan  

Official title:

EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579732
• Other study ID #: 19882
• Status: Completed
• Start date: June 29, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4710504
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Gastrointestinal Neoplasms

Intervention

Drug:
• Aspirin (Acetylsalicylic Acid, BAYE4465)
Low dose of aspirin, i.e. < 150 mg daily

Other:
• No drug
Non-consumers

Locations

Country	Name	City	State
Taiwan	National University of Taiwan Hospital	Taipeh

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Duration of aspirin use to colorectal cancer	The duration of low-dose aspirin use in years to colorectal cancer.	Up to 14 years
Secondary	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
Secondary	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
Secondary	Number of fatal cases due to colorectal cancer	Derived from Taiwan Mortality database.	Up to 14 years