NCT04214990

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,700

participants targeted

Target at P75+ for phase_3

Timeline
72mo left

Started Feb 2020

Longer than P75 for phase_3

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Feb 2020Mar 2032

First Submitted

Initial submission to the registry

December 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2032

Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

11.1 years

First QC Date

December 29, 2019

Last Update Submit

December 25, 2024

Conditions

AspirinGastric Cancer

Keywords

AspirinGastric cancer preventionEndoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

  • The incidence of gastric cancer between the intervention and placebo groups

    Histologically confirmed gastric cancer detected at follow-up endoscopy or registered at the Korean Cancer Registry

    Until last enrolled patients take 5-year trial medication

Secondary Outcomes (6)

  • All-cause mortality

    Until last enrolled patients take 5-year trial medication

  • The incidence of cardiovascular disease and cerebrovascular disease between the intervention and placebo groups

    Until last enrolled patients take 5-year trial medication

  • The incidence of other organ cancers between the intervention and placebo groups

    Until last enrolled patients take 5-year trial medication

  • The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups

    Until last enrolled patients take 5-year trial medication

  • Complication related to the aspirin use

    Until last enrolled patients take 5-year trial medication

  • +1 more secondary outcomes

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Enteric coated aspirin

Drug: Aspirin 100mg

Placebo

PLACEBO COMPARATOR

Enteric coated aspirin placebo

Drug: Placebo oral tablet

Interventions

Aspirin 100mgDRUG

Daily aspirin 100 mg for 5 years

Aspirin
Placebo oral tabletDRUG

Daily placebo for 5 years

Placebo

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Kosin University Gospel Hospital

Busan, 49267, South Korea

RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, 24253, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

RECRUITING

National Cancer Center

Goyang, 10408, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

Incheon St.Mary's Hospital/The Catholic University

Incheon, 21431, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, 06973, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Il Ju Choi, M.D., Ph.D.

    National Cancer Center, Korea

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+82-31-920-2282cij1224@ncc.re.kr

Young-Il Kim, MD

CONTACT

+82-31-920-171211996@ncc.re.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 2, 2020

Study Start

February 15, 2020

Primary Completion (Estimated)

March 31, 2031

Study Completion (Estimated)

March 31, 2032

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(10)