Helicobacter Pylori Eradication to Prevent Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01133951
• Other study ID #: SMMU20100501
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2010
• Est. completion date: May 2032

Study information

• Verified date: October 2023
• Source: Second Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: May 2032
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Stomach Neoplasms

Intervention

Drug:
• OAC triple therapy
Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.
• Placebo
Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.

Locations

Country	Name	City	State
China	Zhao-Lai Hua M.D.	Yangzhong City	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jie-Jun Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric cancer incidence	The incidence of gastric cancer in the two groups	10 years
Secondary	Histopathological changes	The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups	10 years