Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Last updated: November 7, 2023
Sponsor: National Cancer Center, Korea
Overall Status: Active - Not Recruiting

Phase

3

Condition

Stomach Cancer

Digestive System Neoplasms

Gastric Cancer

Treatment

Placebo

LAC triple therapy

Clinical Study ID

NCT01678027
NCCCTS04-103
  • Ages 40-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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, renalfailure, cardiovascular diseases
  • Pregnant or nursing women
  • Psychiatric disorder that would preclude compliance, alcoholics
  • Refuse informed consent

Study Design

Total Participants: 1838
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 01, 2004
Estimated Completion Date:
December 31, 2035

Study 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.

Connect with a study center

  • National Cancer Center, Korea

    Goyang, Gyeonggi 10408
    Korea, Republic of

    Site Not Available

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