Clinical trial NCT01678027: Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication
Official title: Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Helicobacter Pylori Infection
Family Members
Keywords: Stomach neoplasm
Helicobacter pylori
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2012-09-03
Enrollment: 1838
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Gastric cancer incidence
timeFrame: 6 years after last participant enrollment
Secondary outcomes:
measure: Gastric dysplasia incidence
timeFrame: 6 year after last participant enrollment
measure: Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups
timeFrame: 6 year after last participant enrollment
measure: Gastric cancer incidence according to H. pylori status
timeFrame: 6 year after last participant enrollment
measure: All-cause mortality
timeFrame: 6 year after last participant enrollment
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi
Study officials:
affiliation: National Cancer Center, Korea
name: Il Ju Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi IJ, Kim CG, Lee JY, Kim YI, Kook MC, Park B, Joo J. Family History of Gastric Cancer and Helicobacter pylori Treatment. N Engl J Med. 2020 Jan 30;382(5):427-436. doi: 10.1056/NEJMoa1909666.