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

NCT ID: NCT04214990

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2032-03-31

Brief Summary

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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.

Detailed Description

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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 a 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 or high-grade dysplasia patients who underwent endoscopic resection.

Conditions

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Aspirin Gastric Cancer

Keywords

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Aspirin Gastric cancer prevention Endoscopic submucosal dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin

Enteric coated aspirin

Group Type ACTIVE_COMPARATOR

Aspirin 100mg

Intervention Type DRUG

Daily aspirin 100 mg for 5 years

Placebo

Enteric coated aspirin placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Daily placebo for 5 years

Interventions

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Aspirin 100mg

Daily aspirin 100 mg for 5 years

Intervention Type DRUG

Placebo oral tablet

Daily placebo for 5 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 19-70 years who underwent endoscopic resection for high-grade adenoma or early gastric cancer (category 4 \[non-invasive high grade neoplasm\] or category 5 \[invasive neoplasia\] according to the Vienna classification of gastrointestinal epithelial neoplasia \[Schlemper RJ, et al. Gut 2000;47:251-255.\])
* 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

* Patients 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
* Inadequate 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%
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incheon St.Mary's Hospital/The Catholic University

UNKNOWN

Sponsor Role collaborator

Kosin University Gospel Hospital

OTHER

Sponsor Role collaborator

Pusan National University Hospital

OTHER

Sponsor Role collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role collaborator

Chilgok Kyungpook National University

UNKNOWN

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Il Ju Choi

Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Il Ju Choi, M.D., Ph.D.

Role: STUDY_DIRECTOR

National Cancer Center, Korea

Locations

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Pusan National University Hospital

Busan, , South Korea

Site Status RECRUITING

Kosin University Gospel Hospital

Busan, , South Korea

Site Status RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, , South Korea

Site Status RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status RECRUITING

National Cancer Center

Goyang, , South Korea

Site Status RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Incheon St.Mary's Hospital/The Catholic University

Incheon, , South Korea

Site Status RECRUITING

Chung-Ang University Hospital

Seoul, , South Korea

Site Status RECRUITING

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Countries

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South Korea

Central Contacts

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Il Ju Choi, M.D., Ph.D.

Role: CONTACT

Phone: +82-31-920-2282

Email: [email protected]

Young-Il Kim, MD

Role: CONTACT

Phone: +82-31-920-1712

Email: [email protected]

Facility Contacts

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Gwang Ha Kim, M.D., Ph.D.

Role: primary

Moo In Park, M.D., Ph.D.

Role: primary

Gwang Ho Baik, M.D.

Role: primary

Seong Woo Jeon, M.D., Ph.D.

Role: primary

Il Ju Choi, M.D., Ph.D.

Role: primary

Seon-Young Park, M.D., Ph.D.

Role: primary

Byung-Wook Kim, M.D.,Ph.D.

Role: primary

Jae Gyu Kim, M.D., Ph.D.

Role: primary

Ji Won Kim, M.D., Ph.D.

Role: primary

Jeong Hoon Lee, M.D., Ph.D.

Role: primary

Other Identifiers

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NCC2019-0184

Identifier Type: -

Identifier Source: org_study_id