NCT01678027

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,838

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline
116mo left

Started Nov 2004

Longer than P75 for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2004Dec 2035

Study Start

First participant enrolled

November 1, 2004

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
17 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Expected
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

14.1 years

First QC Date

August 17, 2012

Last Update Submit

November 7, 2023

Conditions

Gastric CancerHelicobacter Pylori InfectionFamily Members

Keywords

Stomach neoplasmHelicobacter pylori

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Gastric dysplasia incidence

    6 year after last participant enrollment

  • Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups

    6 year after last participant enrollment

  • Gastric cancer incidence according to H. pylori status

    6 year after last participant enrollment

  • All-cause mortality

    6 year after last participant enrollment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo for LAC triple therapy

Drug: Placebo

LAC triple therapy

ACTIVE COMPARATOR

PPI (Lansoprazole), Clarithromycin, Amoxicilline

Drug: LAC triple therapy

Interventions

PlaceboDRUG

Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.

Placebo
LAC triple therapyDRUG

Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.

Also known as: PPI-Clarithromycin containing triple therapy
LAC triple therapy

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
  • Informed consent should be signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31995688DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Il Ju Choi, M.D., Ph.D.

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D

Study Record Dates

First Submitted

August 17, 2012

First Posted

September 3, 2012

Study Start

November 1, 2004

Primary Completion

December 1, 2018

Study Completion (Estimated)

December 1, 2035

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)