Helicobacter Pylori Eradication to Prevent Gastric Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Jie-Jun Wang
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
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Purpose
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 | Intervention |
|---|---|
|
Helicobacter Infections Stomach Neoplasms |
Drug: OAC triple therapy Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Second Military Medical University:
Primary Outcome Measures:
- Gastric cancer incidence [ Time Frame: 10 years ] [ Designated as safety issue: No ]The incidence of gastric cancer in the two groups
Secondary Outcome Measures:
- Histopathological changes [ Time Frame: 10 years ] [ Designated as safety issue: No ]The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups
| Enrollment: | 3000 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | May 2020 |
| Estimated Primary Completion Date: | May 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 30 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133951
Locations
| China, Jiangsu | |
| 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 |
More Information
No publications provided
| Responsible Party: | Jie-Jun Wang, MD, Second Military Medical University |
| ClinicalTrials.gov Identifier: | NCT01133951 History of Changes |
| Other Study ID Numbers: | SMMU20100501 |
| Study First Received: | May 28, 2010 |
| Last Updated: | June 10, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Second Military Medical University:
|
Helicobacter Infections Helicobacter pylori Drug Therapy |
Precancerous Conditions Stomach Neoplasms Incidence |
Additional relevant MeSH terms:
|
Neoplasms Stomach Neoplasms Helicobacter Infections Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013