Trial Condition(s):
Gastrointestinal Cancer
Effectiveness of low dose Aspirin in decreasing the chance getting stomach and intestine cancer (ENgAGE-HK)
Bayer Identifier:
20319
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations University of Hong Kong Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Effectiveness of low-dose Aspirin in Gastrointestinal cancer prevention – Hong Kong
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- 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)Timeframe: 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)Timeframe: 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)Timeframe: Retrospective analysis between 1st January 2004 and 31st December 2008
Secondary Outcome
- Duration of aspirin useMinimum duration of aspirin use to confer the protective effects in preventing colorectal, gastric and esophageal cancerTimeframe: Retrospective analysis between 1st January 2004 and 31st December 2008
- Risk of colorectal, gastric and esophageal cancer after discontinuation of aspirin useLogistic 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.Timeframe: Retrospective analysis between 1st January 2004 and 31st December 2008
- Case-fatality and survival rateFor colorectal cancer, gastric or oesophagealTimeframe: Retrospective analysis between 1st January 2004 and 31st December 2008
Additional Information
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