Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication
|ClinicalTrials.gov Identifier: NCT01678027|
Recruitment Status : Active, not recruiting
First Posted : September 3, 2012
Last Update Posted : April 29, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Bacterial Infection Due to Helicobacter Pylori (H. Pylori)||Drug: Placebo Drug: LAC triple therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1810 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
Placebo Comparator: Placebo
Placebo for LAC triple therapy
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
- 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.
- Gastric dysplasia incidence [ Time Frame: 6 year after last participant enrollment ]Incidence of gastric dysplasia according to the H. pylori treatment
- Gastric cancer incidence between Hp treatment and Hp uninfected groups [ Time Frame: 6 year after last participant enrollment ]Gastric cancer incidence between Hp treatment and Hp uninfected groups
- Gastric cancer incidence according to final Hp status [ Time Frame: 6 year after last participant enrollment ]Gastric cancer incidence between Hp eradicated and Hp persistent state
- All-cause mortality [ Time Frame: 6 year after last participant enrollment ]All-cause mortality between H. pylori treatment group and placebo group
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678027
|Korea, Republic of|
|National Cancer Center, Korea|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Principal Investigator:||Il Ju Choi, M.D., Ph.D.||National Cancer Center, Korea|