Helicobacter Pylori Eradication to Prevent Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01133951
Recruitment Status : Active, not recruiting
First Posted : May 31, 2010
Last Update Posted : January 6, 2014
Information provided by (Responsible Party):
Jie-Jun Wang, Second Military Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Helicobacter Infections Stomach Neoplasms Drug: OAC triple therapy Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial
Study Start Date : June 2010
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: OAC triple therapy Drug: OAC triple therapy
Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.

Placebo Comparator: Placebo Drug: Placebo
Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.

Primary Outcome Measures :
  1. Gastric cancer incidence [ Time Frame: 10 years ]
    The incidence of gastric cancer in the two groups

Secondary Outcome Measures :
  1. Histopathological changes [ Time Frame: 10 years ]
    The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups

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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01133951

China, Jiangsu
Zhao-Lai Hua M.D.
Yangzhong City, Jiangsu, China, 212200
Sponsors and Collaborators
Jie-Jun Wang
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

Responsible Party: Jie-Jun Wang, MD, Second Military Medical University Identifier: NCT01133951     History of Changes
Other Study ID Numbers: SMMU20100501
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014

Keywords provided by Jie-Jun Wang, Second Military Medical University:
Helicobacter Infections
Helicobacter pylori
Drug Therapy
Precancerous Conditions
Stomach Neoplasms

Additional relevant MeSH terms:
Stomach Neoplasms
Helicobacter Infections
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections