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Completed

NCT Number: NCT04081831

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

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.

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Key information

Conditions

Gastrointestinal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Stomach Diseases Stomach Neoplasms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

Follow clinical administration

Primary outcomes

  1. Incidence rate ratio of colorectal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)

    Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008

    Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)

  2. Incidence rate ratio of gastric cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)

    Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008

    Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)

  3. Incidence rate ratio of esophageal cancer among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)

    Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008

    Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)

Secondary outcomes

  1. Duration of aspirin use

    Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008

    Minimum duration of aspirin use to confer the protective effects in preventing colorectal, gastric and esophageal cancer

  2. Risk of colorectal, gastric and esophageal cancer after discontinuation of aspirin use

    Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008

    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.

  3. Case-fatality and survival rate

    Time frame: Retrospective analysis between 1st January 2004 and 31st December 2008

    For colorectal cancer, gastric or oesophageal

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: ENgAGE-HK

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2019
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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