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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

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 Summary:

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


Sponsor: King Chulalongkorn Memorial Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: King Chulalongkorn Memorial Hospital

Dates:
Date Received: December 5, 2011
Date Started: October 2011
Date Completion: October 2017
Last Updated: June 22, 2012
Last Verified: June 2012