NCT03579732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,710,504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

June 29, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

June 26, 2018

Last Update Submit

September 27, 2020

Conditions

Colorectal Neoplasms

Keywords

Low-dose aspirin,Cancer prevention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Duration of aspirin use to colorectal cancer

    Up to 14 years

  • Time from aspirin discontinuation to colorectal cancer

    Up to 14 years

  • Stage of colorectal cancer

    Up to 14 years

  • Number of fatal cases due to colorectal cancer

    Up to 14 years

Study Arms (4)

Long-term users

Adults using low-dose aspirin for \> 3 years

Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)

Episodic users

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

Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)

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)

Non-consumers

Adults who did not use low-dose aspirin

Other: No drug

Interventions

Aspirin (Acetylsalicylic Acid, BAYE4465)DRUG

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

Episodic usersFormer usersLong-term users
No drugOTHER

Non-consumers

Also known as: No aspirin
Non-consumers

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 40 or older at the cohort entry date.
  • Taiwanese National Health Insurance enrollees with non-missing and consistent age and gender information.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Taiwan Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

AspirinN-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 9, 2018

Study Start

June 29, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

TW(1)