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


N/A
30 Years
59 Years
Open (Enrolling)
Both
Helicobacter Infections, Stomach Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Gastric cancer incidence

Outcome Description:

The incidence of gastric cancer in the two groups

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Jie J Wang, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Shanghai Changzheng Hospital affiliated to Second Military Medical University

Authority:

China: Ministry of Health

Study ID:

SMMU20100501

NCT ID:

NCT01133951

Start Date:

June 2010

Completion Date:

May 2020

Related Keywords:

  • Helicobacter Infections
  • Stomach Neoplasms
  • Helicobacter Infections
  • Helicobacter pylori
  • Drug Therapy
  • Precancerous Conditions
  • Stomach Neoplasms
  • Incidence
  • Neoplasms
  • Stomach Neoplasms
  • Helicobacter Infections

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