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: January 3, 2014
Last verified: January 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 3, 2014
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 September 15, 2014