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Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Il Ju Choi, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01678027
First received: August 17, 2012
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Gastric cancer incidence [ Time Frame: 6 years after last participant enrollment ] [ Designated as safety issue: No ]

    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 cancer incidence [ Time Frame: 6 year after last participant enrollment ] [ Designated as safety issue: No ]
    Incidence of gastric cancer according to the final H. pylori infection status

  • Gastric cancer incidence [ Time Frame: 6 year after last participant enrollment ] [ Designated as safety issue: No ]
    Gastric cancer incidence according to the initial gastric mucosal atrophy grade and intestinal metaplasia grade


Estimated Enrollment: 1810
Study Start Date: November 2004
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
Active Comparator: LAC triple therapy Drug: LAC triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678027

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

No publications provided

Responsible Party: Il Ju Choi, M.D., Ph.D, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01678027     History of Changes
Other Study ID Numbers: NCCSTS04-103
Study First Received: August 17, 2012
Last Updated: August 29, 2012
Health Authority: National Cancer Center, Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
Family history

Additional relevant MeSH terms:
Bacterial Infections
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 16, 2013