check_circleStudy Completed

Colorectal neoplasms

Bayer Identifier:

19882

ClinicalTrials.gov Identifier:

NCT03579732

EudraCT Number:

Not Available

EU CT Number:

Not Available
EffectiveNess of low dose Aspirin in GastrointEstinal cancer prevention - Taiwan

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

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

  • - 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.

Trial summary

Enrollment Goal
4710504
Trial Dates
June 2018 - September 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
National University of Taiwan HospitalTaipeh, 100, Taiwan

Primary Outcome

  • 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).
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    Up to 14 years

Secondary Outcome

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

Trial design

EffectiveNess of low dose Aspirin in GastrointEstinal cancer prevention - Taiwan
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A