NCT01133951

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
73mo left

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jun 2010May 2032

First Submitted

Initial submission to the registry

May 28, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
20.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2032

Expected
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

May 28, 2010

Last Update Submit

October 9, 2023

Conditions

Helicobacter InfectionsStomach Neoplasms

Keywords

Helicobacter InfectionsHelicobacter pyloriDrug TherapyPrecancerous ConditionsStomach NeoplasmsIncidence

Outcome Measures

Primary Outcomes (1)

  • Gastric cancer incidence

    The incidence of gastric cancer in the two groups

    10 years

Secondary Outcomes (1)

  • Histopathological changes

    10 years

Study Arms (2)

OAC triple therapy

EXPERIMENTAL
Drug: OAC triple therapy

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OAC triple therapyDRUG

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

OAC triple therapy
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age30 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhao-Lai Hua M.D.

Yangzhong, Jiangsu, 212200, China

Location

MeSH Terms

Conditions

Helicobacter InfectionsStomach NeoplasmsPrecancerous Conditions

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jie J Wang, M.D.

    Shanghai Changzheng Hospital affiliated to Second Military Medical University

    STUDY CHAIR

  • Xi Wang, M.D.

    Shanghai Changzheng Hospital affiliated to Second Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 28, 2010

First Posted

May 31, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2012

Study Completion (Estimated)

May 1, 2032

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

CN(1)