check_circleStudy Completed

Gastrointestinal Cancer

Bayer Identifier:

20319

ClinicalTrials.gov Identifier:

NCT04081831

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effectiveness of low dose Aspirin in decreasing the chance getting stomach and intestine cancer

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.

Key Participants Requirements

Sex

All

Age

40 - N/A
  • - Received prescription of either low-dose aspirin (75-300 mg) or paracetamol monotherapy during enrolment period.

  • - 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
99999
Trial Dates
July 2019 - August 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University of Hong KongHong Kong, Hong Kong

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)
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    Retrospective analysis between 1st January 2004 and 31st December 2008

Secondary Outcome

  • Duration of aspirin use
    Minimum duration of aspirin use to confer the protective effects in preventing colorectal, gastric and esophageal cancer
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Retrospective analysis between 1st January 2004 and 31st December 2008
  • Case-fatality and survival rate
    For colorectal cancer, gastric or oesophageal
    date_rangeTime Frame:
    Retrospective analysis between 1st January 2004 and 31st December 2008

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
N/A

Additional Information

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