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 : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Helicobacter Pylori Infection Family Members||Drug: Placebo Drug: LAC triple therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1837 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2023|
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 H. pylori treatment and H. pylori uninfected groups [ Time Frame: 6 year after last participant enrollment ]Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group
- Gastric cancer incidence according to H. pylori status [ Time Frame: 6 year after last participant enrollment ]Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group
- 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, 10408|
|Principal Investigator:||Il Ju Choi, M.D., Ph.D.||National Cancer Center, Korea|