Clinical trial NCT01133951: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Helicobacter Infections
Stomach Neoplasms
Keywords: Helicobacter Infections
Helicobacter pylori
Drug Therapy
Precancerous Conditions
Stomach Neoplasms
Incidence
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Gastric cancer incidence
timeFrame: 10 years
Secondary outcomes:
measure: Histopathological changes
timeFrame: 10 years
Other outcomes:
Locations:
city: Yangzhong City
country: China
facility: Zhao-Lai Hua M.D.
state: Jiangsu
Study officials:
affiliation: Shanghai Changzheng Hospital affiliated to Second Military Medical University
name: Jie J Wang, M.D.
role: STUDY_CHAIR
affiliation: Shanghai Changzheng Hospital affiliated to Second Military Medical University
name: Xi Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: