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Trial Title:
Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication
NCT ID:
NCT01678027
Condition:
Gastric Cancer
Helicobacter Pylori Infection
Family Members
Conditions: Official terms:
Stomach Neoplasms
Clarithromycin
Conditions: Keywords:
Stomach neoplasm
Helicobacter pylori
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Placebo
Description:
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day
for 1 week.
Arm group label:
Placebo
Intervention type:
Drug
Intervention name:
LAC triple therapy
Description:
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for
1 week.
Arm group label:
LAC triple therapy
Other name:
PPI-Clarithromycin containing triple therapy
Summary:
This study evaluate whether treatment of Helicobacter pylori infection reduces the
incidence of gastric cancer in subjects with family history of gastric cancer.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
40 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
National Cancer Center, Korea
Address:
City:
Goyang
Zip:
10408
Country:
Korea, Republic of
Start date:
November 2004
Completion date:
December 2035
Lead sponsor:
Agency:
National Cancer Center, Korea
Agency class:
Other
Source:
National Cancer Center, Korea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01678027
