NCT02112214

Brief Summary

The aim of this study is to define the role of H. pylori eradication in the prevention of gastric cancer and its precursors in the context of a population-based endoscopic screening program.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
5,224

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline
44mo left

Started Jun 2014

Longer than P75 for phase_3 gastric-cancer

Geographic Reach
1 country

11 active sites

Status
active not 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 Progress77%
Jun 2014Dec 2029

First Submitted

Initial submission to the registry

April 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
15.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

15.5 years

First QC Date

April 3, 2014

Last Update Submit

December 25, 2024

Conditions

Gastric CancerHelicobacter Pylori Infection

Keywords

Helicobacter pylori treatmentGastric cancerScreening

Outcome Measures

Primary Outcomes (1)

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

    Histologically confirmed gastric adenocarcinoma stage 1A or more advanced defined at endoscopy or through cancer registry

    Up to 10 years After H. pylori eradication

Secondary Outcomes (6)

  • Incidence of gastric dysplasia

    Up to 10 years After H. pylori eradication

  • Occurrence of adverse events caused by antibiotic treatment

    During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion

  • Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment

    Up to 10 years After H. pylori eradication

  • Mortality from gastric cancer

    Up to 10 years after eradication

  • All-cause mortality

    Up to 10 years After H. pylori eradication

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

10-day bismuth-based quadruple therapy for H. pylori positive subjects

Drug: 10-day bismuth-based quadruple therapy

Placebo group

PLACEBO COMPARATOR

Placebo for H. pylori positive subjects

Other: Placebo

Interventions

10-day bismuth-based quadruple therapyDRUG

Bismuth 300 mg (4 times a day), lansoprazole 30 mg (twice a day), metronidazole 500 mg (3 times a day), and tetracycline 500 mg (4 times a day) for 10 days

Also known as: Bismuth-based quadruple therapy
Intervention group
PlaceboOTHER

Placebo for bismuth-based quadruple therapy

Placebo group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 40-65 who are invited to participate in the National Cancer Screening Program and receive upper endoscopy
  • Willingness to sign an informed consent form
  • Good health, as determined by medical history and physical examination at enrollment

You may not qualify if:

  • Personal history of gastric cancer
  • Family history of gastric cancer in a first degree relative
  • Diagnosis and active treatment for other organ cancer except carcinoma in situ within 5 years
  • Current treatment for serious medical condition which could hinder participation (such as liver cirrhosis, renal failure, pulmonary dysfunction including COPD or asthma, or uncontrolled infection)
  • Inadequate cardiovascular function including (a) New York Heart Association class III or IV heart disease, (b) unstable angina or myocardial infarction history, (c) history of significant ventricular arrhythmia requiring medication with antiarrhythmics, and (d) history of cerebrovascular accident
  • Requirement for therapeutic anticoagulant therapy, aspirin
  • Gastric resections due to benign disease
  • H. pylori eradication therapy history
  • Mental incompetence to understand and sign informed consent
  • Alcoholism, drug abuse
  • Serious chronic diseases according to the evaluation of the study physician
  • Presence of a contraindication to the use of eradication treatment regimens
  • Inability to provide an informed consent
  • Pregnant or lactating women
  • Treatment required due to peptic ulcer, gastric cancer or esophageal cancer identified during the endoscopic examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Pusan National University Hospital

Busan, 620-739, South Korea

Location

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, 24253, South Korea

Location

Kyungpook National University Hospital

Daegu, 702-911, South Korea

Location

National Cancer Center

Goyang, 410-769, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Incheon St.Mary's Hospital/The Catholic University

Incheon, 21431, South Korea

Location

Kandong Sacred Heart Hospital

Seoul, 05355, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Chung-Ang University Hospital

Seoul, 156-861, South Korea

Location

Uijeongbu St. Mary's Hospital/The Catholic University

Uijeongbu-si, 480-821, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Il Ju Choi, M.D., Ph.D.

    National Cancer Center, Korea

    STUDY DIRECTOR

  • Rolando Herrero, M.D.,Ph.D

    International Agency for Research on Cancer

    PRINCIPAL INVESTIGATOR

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
Head of Gastric Cancer Cencer

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 11, 2014

Study Start

June 1, 2014

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

KR(11)