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

• Conditions: Gastric Intestinal Metaplasia

• Registration Number: NCT01490541
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-09
• Study First Posted: 2011-12-13
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-25
• Primary Completion: 2012-12
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. All patients were diagnosed GIM
2. All patients have to sign the consent form

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rapat Pittayanon; 🇹🇭 Bangkok, Thailand