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Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

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ClinicalTrials.gov Identifier: NCT01678027
Recruitment Status : Active, not recruiting
First Posted : September 3, 2012
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Il Ju Choi, National Cancer Center, Korea

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Helicobacter Pylori Infection Family Members Drug: Placebo Drug: LAC triple therapy Phase 3

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  (Clinical Trial)
Actual Enrollment : 1837 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study
Study Start Date : November 2004
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: PPI-Clarithromycin containing triple therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678027


Locations
Korea, Republic of
National Cancer Center, Korea
Goyang, Gyeonggi, Korea, Republic of, 10408
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Il Ju Choi, M.D., Ph.D. National Cancer Center, Korea

Responsible Party: Il Ju Choi, M.D., Ph.D, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01678027     History of Changes
Other Study ID Numbers: NCCCTS04-103
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Il Ju Choi, National Cancer Center, Korea:
Stomach neoplasm
Helicobacter pylori

Additional relevant MeSH terms:
Stomach Neoplasms
Helicobacter Infections
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Lansoprazole
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