Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

November 7, 2023 updated by: Il Ju Choi, National Cancer Center, Korea

Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study

This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Helicobacter pylori infection is associated with gastric cancer in epidemiological studies. However, it is still unknown whether H. pylori eradication is useful and required to prevent gastric cancer.

Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients.

In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.

Study Type

Interventional

Enrollment (Actual)

1838

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 10408
        • National Cancer Center, Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
  • Informed consent should be signed

Exclusion Criteria:

  • Gastric cancer history
  • Other malignancy within the past 5 years
  • Hereditary cancer family member (HNPCC, FAP)
  • Peptic ulcer history
  • Peptic ulcer, esophageal cancer, gastric cancer case found at EGD
  • H. pylori eradication treatment history
  • Previous serious side effect to antibiotics
  • Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
  • Pregnant or nursing women
  • Psychiatric disorder that would preclude compliance, alcoholics
  • Refuse informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for LAC triple therapy
Drug: Placebo
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
Active Comparator: LAC triple therapy
PPI (Lansoprazole), Clarithromycin, Amoxicilline
Drug: LAC triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
Other Names:
  • PPI-Clarithromycin containing triple therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric cancer incidence
Time Frame: 6 years after last participant enrollment

The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status.

Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.
6 years after last participant enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric dysplasia incidence
Time Frame: 6 year after last participant enrollment
Incidence of gastric dysplasia according to the H. pylori treatment
6 year after last participant enrollment
Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups
Time Frame: 6 year after last participant enrollment
Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group
6 year after last participant enrollment
Gastric cancer incidence according to H. pylori status
Time Frame: 6 year after last participant enrollment
Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group
6 year after last participant enrollment
All-cause mortality
Time Frame: 6 year after last participant enrollment
All-cause mortality between H. pylori treatment group and placebo group
6 year after last participant enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Il Ju Choi, M.D., Ph.D., National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

December 1, 2018

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimated)

September 3, 2012

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS04-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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