Helicobacter Pylori Eradication to Prevent Gastric Cancer

NCT ID: NCT01133951

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2032-05-31

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.

Conditions

Helicobacter Infections; Stomach Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

OAC triple therapy

Group Type: EXPERIMENTAL

OAC triple therapy

Intervention Type: DRUG

Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.

Interventions

OAC triple therapy

Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.

Intervention Type: DRUG

Placebo

Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jie-Jun Wang

OTHER

Sponsor Role: lead

Responsible Party

Jie-Jun Wang

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jie J Wang, M.D.

Role: STUDY_CHAIR

Shanghai Changzheng Hospital affiliated to Second Military Medical University

Xi Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital affiliated to Second Military Medical University

Locations

Zhao-Lai Hua M.D.

Yangzhong, Jiangsu, China

Countries

China

Other Identifiers

SMMU20100501

Identifier Type: -

Identifier Source: org_study_id