Effectiveness of Low Dose Aspirin in Decreasing the Chance Getting Stomach and Intestine Cancer (ENgAGE-HK)

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

• Study Type: Observational
• Enrollment (Actual): 99999

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥ 40 years who received low dose aspirin (75-300 mg) or paracetamol between 1st January 2004 and 31st December 2008 will be identified from CDARS (Clinical Data Analysis and Reporting System). CDARS is an electronic clinical database which is managed by the Hospital Authority (HA). More than seven million Hong Kong citizens have access to public healthcare services provided by HA.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
New-users of Low-dose aspirin (exposed group); New-users of low-dose aspirin is defined as patients who did not receive any prescriptions of low-dose aspirin one year prior to the index date.	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Follow clinical administration
Users of Paracetamol (non-exposed group); Users of Paracetamol is defined as patients who receive first prescription of paracetamol during the study period. Since the patients receiving low-dose aspirin are potentially less healthy compared to non-users of aspirin, patients receiving paracetamol as the control group can minimise healthy user bias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Case-fatality and survival rate	For colorectal cancer, gastric or oesophageal	Retrospective analysis between 1st January 2004 and 31st December 2008

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer Healthcare products.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Actual): August 25, 2020
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal cancer; Gastric cancer; Esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 20319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No