Helicobacter Pylori Eradication to Prevent Gastric Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Jie-Jun Wang, Second Military Medical University

ClinicalTrials.gov Identifier:

NCT01133951

First received: May 28, 2010

Last updated: June 10, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 28, 2010

Last Updated Date

June 10, 2012

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

May 2020 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Gastric cancer incidence [ Time Frame: 10 years ] [ Designated as safety issue: No ]

The incidence of gastric cancer in the two groups

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01133951 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Histopathological changes [ Time Frame: 10 years ] [ Designated as safety issue: No ]

The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Helicobacter Pylori Eradication to Prevent Gastric Cancer

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Helicobacter Infections
Stomach Neoplasms

Intervention ^ICMJE

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

Study Arm (s)

Experimental: OAC triple therapy
Intervention: Drug: OAC triple therapy
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

3000

Estimated Completion Date

May 2020

Estimated Primary Completion Date

May 2020 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 59 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01133951

Other Study ID Numbers ^ICMJE

SMMU20100501

Has Data Monitoring Committee

Yes

Responsible Party

Jie-Jun Wang, Second Military Medical University

Study Sponsor ^ICMJE

Jie-Jun Wang

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Second Military Medical University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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