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NCT Number: NCT01133951

Helicobacter Pylori Eradication to Prevent Gastric Cancer

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.

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Key information

Conditions

Helicobacter Infections Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gram-Negative Bacterial Infections Infections Neoplasms Neoplasms by Site Precancerous Conditions Stomach Diseases Stomach Neoplasms

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhao-Lai Hua M.D.

Yangzhong, Jiangsu, 212200, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OAC triple therapy

Drug

Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.

Placebo

Drug

Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.

Primary outcomes

  1. Gastric cancer incidence

    Time frame: 10 years

    The incidence of gastric cancer in the two groups

Secondary outcomes

  1. Histopathological changes

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

Jie-Jun Wang

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2032
First posted
May 31, 2010
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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