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Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Il Ju Choi, National Cancer Center, Korea Identifier:
First received: August 17, 2012
Last updated: April 28, 2016
Last verified: April 2016

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.

Condition Intervention Phase
Gastric Cancer Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Drug: Placebo Drug: LAC triple therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study

Resource links provided by NLM:

Further study details as provided by Il Ju Choi, National Cancer Center, Korea:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Gastric dysplasia incidence [ Time Frame: 6 year after last participant enrollment ]
    Incidence of gastric dysplasia according to the H. pylori treatment

  • Gastric cancer incidence between Hp treatment and Hp uninfected groups [ Time Frame: 6 year after last participant enrollment ]
    Gastric cancer incidence between Hp treatment and Hp uninfected groups

  • Gastric cancer incidence according to final Hp status [ Time Frame: 6 year after last participant enrollment ]
    Gastric cancer incidence between Hp eradicated and Hp persistent state

  • All-cause mortality [ Time Frame: 6 year after last participant enrollment ]
    All-cause mortality between H. pylori treatment group and placebo group

Estimated Enrollment: 1810
Study Start Date: November 2004
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PPI-Clarithromycin containing triple therapy


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01678027

Korea, Republic of
National Cancer Center, Korea
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Principal Investigator: Il Ju Choi, M.D., Ph.D. National Cancer Center, Korea
  More Information

Responsible Party: Il Ju Choi, M.D., Ph.D, National Cancer Center, Korea Identifier: NCT01678027     History of Changes
Other Study ID Numbers: NCCSTS04-103
Study First Received: August 17, 2012
Last Updated: April 28, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Il Ju Choi, National Cancer Center, Korea:
Family history

Additional relevant MeSH terms:
Stomach Neoplasms
Bacterial Infections
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors processed this record on August 22, 2017