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NCT04081831 Clinical Trial

Effectiveness of Low Dose Aspirin in Decreasing the Chance Getting Stomach and Intestine Cancer

Gastrointestinal Cancer Clinical Trial

— ENgAGE-HK  

Official title:
Effectiveness of Low-dose Aspirin in Gastrointestinal Cancer Prevention - Hong Kong

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04081831
Other study ID # 20319
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2019
Est. completion date August 25, 2020

Study information
Verified date April 2022
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, researchers wanted to learn more about the effect of Aspirin taken as low dose (75 - 300 mg) in preventing stomach, colorectal and esophagus cancer. The researchers were interested in the effect by duration of aspirin use and the effect on the time since aspirin intake has been stopped in preventing stomach, colorectal and esophagus cancer. In addition, the study also looked into the time patients survived after being diagnosed (survival rate) with cancer and number of cancer patients who died (case fatality rate). The study was based on an electronic database managed by the Health Authority in Hong Kong containing anonymized clinical information of patients living in Hong Kong.

Recruitment information / eligibility
Status Completed
Enrollment 99999
Est. completion date August 25, 2020
Est. primary completion date August 25, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Received prescription of either low-dose aspirin (75-300 mg) or paracetamol monotherapy during enrolment period. Exclusion Criteria: - Received prescription of aspirin monotherapy or combination one year prior to the index date - Recorded diagnoses of any type of cancer before the index date - Recorded procedures of colectomy, gastrectomy prior to the index date - Age < 40 years

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Acetylsalicylic Acid (Aspirin, BAYE4465)
Follow clinical administration

Locations
Country Name City State
Hong Kong University of Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence rate ratio of colorectal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed) Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed) Retrospective analysis between 1st January 2004 and 31st December 2008
Primary Incidence rate ratio of gastric cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed) Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed) Retrospective analysis between 1st January 2004 and 31st December 2008
Primary Incidence rate ratio of esophageal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed) Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed) Retrospective analysis between 1st January 2004 and 31st December 2008
Secondary Duration of aspirin use Minimum duration of aspirin use to confer the protective effects in preventing colorectal, gastric and esophageal cancer Retrospective analysis between 1st January 2004 and 31st December 2008
Secondary Risk of colorectal, gastric and esophageal cancer after discontinuation of aspirin use Logistic regression will be conducted based on nested case-control study with stratification on the recency of exposure with current use, past use, and distant use of aspirin. Retrospective analysis between 1st January 2004 and 31st December 2008
Secondary Case-fatality and survival rate For colorectal cancer, gastric or oesophageal Retrospective analysis between 1st January 2004 and 31st December 2008
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