An observational study in Colorectal Neoplasms, sponsored by Bayer. Completed at 1 site in Taiwan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-09-29.
Sponsored by Bayer · Observational
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 4,710,504 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be selected from the Taiwanese National Health Insurance (NIH) database.
Exclusion Criteria:
Adults using low-dose aspirin for \> 3 years
Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)
Adults using low-dose aspirin inconsistently, or consistently but \< 3 years
Drug: Aspirin (Acetylsalicylic Acid, BAYE4465)
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)
Adults who did not use low-dose aspirin
Other: No drug
Low dose of aspirin, i.e. \< 150 mg daily
Non-consumers
Also known as: No aspirin
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).
Time 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).
Time 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).
Time frame: Up to 14 years
Duration of aspirin use to colorectal cancer
The duration of low-dose aspirin use in years to colorectal cancer.
Time 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.
Time 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).
Time frame: Up to 14 years
Number of fatal cases due to colorectal cancer
Derived from Taiwan Mortality database.
Time frame: Up to 14 years
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bayer