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NCT Number: NCT01678027

Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Family Members Gastrointestinal Diseases Gastrointestinal Neoplasms Helicobacter Pylori Infection Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 10408, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.

LAC triple therapy

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Gastric dysplasia incidence

    Time frame: 6 year after last participant enrollment

    Incidence of gastric dysplasia according to the H. pylori treatment

  2. 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

  3. 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

  4. All-cause mortality

    Time frame: 6 year after last participant enrollment

    All-cause mortality between H. pylori treatment group and placebo group

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2018
Study completion
2035
First posted
Sep 3, 2012
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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