NCT01133951Active, not recruiting
Helicobacter Pylori Eradication to Prevent Gastric Cancer
Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Oct 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 3000 (actual)
- First submitted
- 28 May 2010
- Start date
- Jun 2010
- Primary completion date
- Jan 2012
- Lead sponsor
- Jie-Jun Wang
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT01133951
What you commit to
- Study type: Interventional
- Participants enrolled: 3000
- From Jun 2010 to the primary completion date, Jan 2012
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Previous diagnosis of cancer
- Drug abuse and drug dependence
- Previous history of H pylori eradication treatment
Other illness
- Patients with epilepsy or severe mental illness
- A history of esophageal or gastric surgery
- Allergic to omeprazole, amoxicillin, or clarithromycin
- A definite indication of H. pylori eradication (eg, gastric or duodenum ulcer)
- Other factors or conditions might influence the results of study
Other
- Pregnant and lactating women
- A negative 13C-urea breath test (UBT)
- Dysplasia or carcinoma lesions are found in esophageal or gastric histopathological examination
Who the study is looking for
- 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
Age in the registry: 30 years to 59 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhao-Lai Hua M.D. Coordinator of this site? Confirm its status | Yangzhong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.