Back to resultsHelicobacter Pylori Eradication to Prevent Gastric Cancer
Primary Purpose
Helicobacter Infections, Stomach Neoplasms
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
OAC triple therapy
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Helicobacter Infections focused on measuring Helicobacter Infections, Helicobacter pylori, Drug Therapy, Precancerous Conditions, Stomach Neoplasms, Incidence
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
Sites / Locations
- Zhao-Lai Hua M.D.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OAC triple therapy
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Gastric cancer incidence
The incidence of gastric cancer in the two groups
Secondary Outcome Measures
Histopathological changes
The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01133951
Brief Title
Helicobacter Pylori Eradication to Prevent Gastric Cancer
Official Title
Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
May 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jie-Jun Wang
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Infections, Stomach Neoplasms
Keywords
Helicobacter Infections, Helicobacter pylori, Drug Therapy, Precancerous Conditions, Stomach Neoplasms, Incidence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OAC triple therapy
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OAC triple therapy
Intervention Description
Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.
Primary Outcome Measure Information:
Title
Gastric cancer incidence
Description
The incidence of gastric cancer in the two groups
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Histopathological changes
Description
The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie J Wang, M.D.
Organizational Affiliation
Shanghai Changzheng Hospital affiliated to Second Military Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xi Wang, M.D.
Organizational Affiliation
Shanghai Changzheng Hospital affiliated to Second Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhao-Lai Hua M.D.
City
Yangzhong City
State/Province
Jiangsu
ZIP/Postal Code
212200
Country
China
12. IPD Sharing Statement
Learn more about this trial
Helicobacter Pylori Eradication to Prevent Gastric Cancer
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