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Clinical Trials/NCT01490541
NCT01490541
Unknown
Not Applicable

The Predictive Scores for Gastric Cancer in Gastric Intestinal Metaplasia (GIM) Patient: a Recommendation for Thai Population

King Chulalongkorn Memorial Hospital1 site in 1 country280 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Intestinal Metaplasia
Sponsor
King Chulalongkorn Memorial Hospital
Enrollment
280
Locations
1
Primary Endpoint
The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population
Last Updated
13 years ago

Overview

Brief Summary

The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a recommendation for Thai population.

Objective:

To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM) patient in order to propose the appropriate recommendation for Thai people.

Research Design:

Single center, retrospective-cohort study.

Detailed Description

Study population and Sample size at Faculty of Medicine, Chulalongkorn University The patients who were diagnosed gastric intestinal metaplasia from 1997 to 2012 and then follow up for 5 years. Estimate sample size =280 * Investigational product, dosage \& route of administration * Questionnaire for explore the risk factors * EGD with biopsy * Blood sampling for gastro panel * Duration of participation * 5 years or until diagnose gastric cancer Statistical method: Unconditional-binary-logistic regression

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
October 2017
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rapat Pittayanon, MD

Principle investigator

King Chulalongkorn Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • All patients were diagnosed GIM
  • All patients have to sign the consent form

Exclusion Criteria

  • Previous gastric surgery including gastrectomy and bypass surgery
  • Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
  • HIV infection
  • History of proton pump inhibitor use within 1 week
  • History of antibiotic use within 4 weeks

Outcomes

Primary Outcomes

The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population

Time Frame: Up to 5 years

In Thailand, gastric cancer patients usually presented with advance stage and carried the dismal prognosis. GIM is a well known precancerous lesion. The appropriate follow-up period in high risk GIM patient can increase the prevalence of early gastric cancer and reduce the mortality rate of gastric cancer

Study Sites (1)

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