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Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication
Conditions
Gastric Cancer - Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Conditions: official terms
Bacterial Infections - Stomach Neoplasms
Conditions: Keywords
Family history
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Intervention
Name: Placebo
Type: Drug
Name: LAC triple therapy
Type: Drug
Overall Status
Recruiting
Summary
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.
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
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 65 Years
Minimum Age: 40 Years
Gender: Both
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
- 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
Location
National Cancer Center, Korea
Goyang, Gyeonggi, Korea, Republic of
Status: Recruiting
Contact: Il Ju Choi, M.D., Ph.D. - +82-31-920-2282 - cij1224@hanmail.net
Start Date
November 2004
Sponsors
National Cancer Center, Korea
Source
National Cancer Center, Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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