Helicobacter Pylori Eradication to Prevent Gastric Cancer

Sponsor

Jie-Jun Wang (Other)

Overall Status

Unknown status

CT.gov ID

NCT01133951

Collaborator

(none)

3,000

Enrollment

Location

Arms

119

Duration (Months)

25.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jun 1, 2010

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Gastric cancer incidence [10 years]
The incidence of gastric cancer in the two groups

Secondary Outcome Measures

Histopathological changes [10 years]
The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 59 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhao-Lai Hua M.D.	Yangzhong City	Jiangsu	China	212200

Sponsors and Collaborators

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