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Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Primary Purpose

Gastric Cancer, Helicobacter Pylori Infection, Family Members

Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
LAC triple therapy
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring Stomach neoplasm, Helicobacter pylori

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Cancer Center, Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

LAC triple therapy

Arm Description

Placebo for LAC triple therapy

PPI (Lansoprazole), Clarithromycin, Amoxicilline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Gastric dysplasia incidence
Incidence of gastric dysplasia according to the H. pylori treatment
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
Gastric cancer incidence according to H. pylori status
Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group
All-cause mortality
All-cause mortality between H. pylori treatment group and placebo group

Full Information

First Posted
August 17, 2012
Last Updated
April 8, 2022
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01678027
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Helicobacter Pylori Infection, Family Members
Keywords
Stomach neoplasm, Helicobacter pylori

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1838 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for LAC triple therapy
Arm Title
LAC triple therapy
Arm Type
Active Comparator
Arm Description
PPI (Lansoprazole), Clarithromycin, Amoxicilline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
Intervention Type
Drug
Intervention Name(s)
LAC triple therapy
Other Intervention Name(s)
PPI-Clarithromycin containing triple therapy
Intervention Description
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
Primary Outcome Measure Information:
Title
Gastric cancer incidence
Description
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.
Time Frame
6 years after last participant enrollment
Secondary Outcome Measure Information:
Title
Gastric dysplasia incidence
Description
Incidence of gastric dysplasia according to the H. pylori treatment
Time Frame
6 year after last participant enrollment
Title
Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups
Description
Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group
Time Frame
6 year after last participant enrollment
Title
Gastric cancer incidence according to H. pylori status
Description
Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group
Time Frame
6 year after last participant enrollment
Title
All-cause mortality
Description
All-cause mortality between H. pylori treatment group and placebo group
Time Frame
6 year after last participant enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, M.D., Ph.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Korea
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
10408
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31995688
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.
Results Reference
derived

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Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

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