Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    1700
  • sponsor
    National Cancer Center, Korea
Updated on 19 February 2024
cancer
aspirin
cancer treatment
gastric cancer
endoscopic submucosal dissection
early gastric cancer
prevention of gastric cancer

Summary

This study aimed to investigate the effect of low-dose (100 mg) asprin on the prevention of gastric cancer in the early gastric cancer patients with negative H. pylori status who underwent endoscopic submucosal dissection.

Description

Aspirin has been widely used as an anti-platelet drug for the primary or secondary prevention of cardiovascular events, including ischemic heart disease and stroke. In 2016, the U.S. Preventive Services Task Force recommended initiating low-dose aspirin use for the primary prevention of cardiovascular diseases and colorectal cancer in adult aged 50 to 59 years who have a 10% or greater 10-year cardiovascular disease risk, are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years. In addition, a meta-analysis reported that long-term aspirin use was associated with reduced the risk of gastrointestinal cancers including colorectal cancer, esophageal cancer, and gastric cancer.However, most studies that reported the cancer prevention effect of long-term aspirin use were conducted as the secondary analysis or subgroup analysis of primary studies investigating the aspirin use for cardiovascular disease prevention. Thus, there is a limitation that appropriate sample sizes and follow-up periods for the cancer prevention effect of aspirin were not considered. In 2018, we reported that H. pylori treatment reduced the development of metachronous gastric cancer after endoscopic resection in early gastric cancer patients. However, metachronous gastric cancer could develop after successful H. pylori eradication with an annual incidence of 1%-3%. Therefore, we designed a multi-center, double-blind, randomized, placebo-controlled trial to evaluate whether long-term low-dose (100 mg) aspirin uses prevents gastric cancer in early gastric cancer patients without H. pylori infection.

Details
Condition Gastropathy, Gastric Cancer, Gastric Cancer, Aspirin
Age 19years - 70years
Treatment Placebo Oral Tablet, Aspirin 100mg
Clinical Study IdentifierNCT04214990
SponsorNational Cancer Center, Korea
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women aged 19-70 who underwent endoscopic resection for early gastric cancer
Final pathological results after endoscopic resection met the absolute or expanded criteria according to the Japanese Gastric Cancer Treatment guideline 2014 (version 4)
Patients who had negative H. pylori status or those who eradicated H. pylori status
Willingness to sign an informed consent form

Exclusion Criteria

Pateints who received aspirin for the secondary prevention of cardiovascular diseases or cerebrovascular diseases
Regular aspirin uses (more than 3 times a week) with 2 months before screening visit
Patients who used anticoagulants or antiplatelet drugs for therapeutic purpose
Previous gastrectomy history
Current treatment for serious medical condition which could hinder participation (such as severe heart dysfunction, liver cirrhosis, renal failure, COPD or bronchial asthma, or uncontrolled infection)
High risk patients for bleeding complications (cerebral aneurysm, vascular malformation, esophageal or gastric varices, or hemophilia, etc)
Active peptic ulcer disease (patients who treated peptic ulcer completely could be enrolled)
Diagnosis and active treatment for other organ cancer (except carcinoma in situ, and non-melanoma skin cancer) within 5 years
Non-curative resection of early gastric cancer after endoscopic resection
Aspirin allergy or contraindication of aspirin use
Pregnant or lactating women
Alcoholism, drug abuse
Inadequte patients for study enrollment according to the evaluation of the study physician
Inability to provide an informed consent
Patients who took a 28-day run-in-period medication less than 80%
Clear my responses

How to participate?

Step 1 Connect with a study center
Entire World
Results (9 sites found)
  • 1

    Pusan National University Hospital

    Korea, Republic of

  • 2

    Kosin University Gospel Hospital

    Korea, Republic of

  • 3

    Hallym University Chuncheon Sacred Heart Hospital

    Korea, Republic of

  • 4

    Chilgok Kyungpook National University Hospital

    Korea, Republic of

  • 5

    National Cancer Center

    Korea, Republic of

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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