Helicobacter Pylori Eradication to Prevent Gastric Cancer

October 9, 2023 updated by: Jie-Jun Wang

Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial

Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection appears to reduce the risk of gastric cancer. However, several recent controlled interventional trials by H. pylori eradication to prevent gastric cancer have yielded disappointing results. The exact effect of H.pylori eradication on prevention of gastric cancer is unclear up to now. To clarify this problem, the investigators conducted a prospective, randomized, double-blind, placebo-controlled, population-based study to determine whether H pylori eradication would reduce the incidence of gastric cancer in a high-risk population in China.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Yangzhong City, Jiangsu, China, 212200
        • Zhao-Lai Hua M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy registered inhabitants from 10 villages in a high-risk county of gastric cancer in China
  • Age 30-59 years
  • A willingness to participate in the study as indicated by written informed consent

Exclusion Criteria:

  • Severe concomitant illness (eg, severe hypertension, coronary heart disease, diabetes mellitus, stroke, asthma, liver cirrhosis, tuberculosis, infectious hepatitis, and cardiac, respiratory, hepatic, or renal insufficiency)
  • Patients with epilepsy or severe mental illness
  • Previous diagnosis of cancer
  • A history of esophageal or gastric surgery
  • Drug abuse and drug dependence
  • Allergic to omeprazole, amoxicillin, or clarithromycin
  • Pregnant and lactating women
  • Previous history of H pylori eradication treatment
  • A negative 13C-urea breath test (UBT)
  • A definite indication of H. pylori eradication (eg, gastric or duodenum ulcer)
  • Dysplasia or carcinoma lesions are found in esophageal or gastric histopathological examination
  • Other factors or conditions might influence the results of study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.
Experimental: OAC triple therapy
Drug: OAC triple therapy
Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric cancer incidence
Time Frame: 10 years
The incidence of gastric cancer in the two groups
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histopathological changes
Time Frame: 10 years
The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jie-Jun Wang

Investigators

  • Study Chair: Jie J Wang, M.D., Shanghai Changzheng Hospital affiliated to Second Military Medical University
  • Principal Investigator: Xi Wang, M.D., Shanghai Changzheng Hospital affiliated to Second Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (Estimated)

May 31, 2010

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMMU20100501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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