Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Gastric Cancer Clinical Trial

Official title:

Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01678027
• Other study ID #: NCCCTS04-103
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2004
• Est. completion date: December 2035

Study information

• Verified date: November 2023
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1838
• Est. completion date: December 2035
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Family Members
• Gastric Cancer
• Helicobacter Pylori Infection
• Stomach Neoplasms

Intervention

Drug:
• Placebo
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
• LAC triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric cancer incidence	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.	6 years after last participant enrollment
Secondary	Gastric dysplasia incidence	Incidence of gastric dysplasia according to the H. pylori treatment	6 year after last participant enrollment
Secondary	Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups	Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group	6 year after last participant enrollment
Secondary	Gastric cancer incidence according to H. pylori status	Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group	6 year after last participant enrollment
Secondary	All-cause mortality	All-cause mortality between H. pylori treatment group and placebo group	6 year after last participant enrollment