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

Gastric Intestinal Metaplasia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01490541
• Other study ID #: RP003
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2011
• Last updated: June 22, 2012
• Start date: October 2011
• Est. completion date: October 2017

Study information

• Verified date: June 2012
• Source: King Chulalongkorn Memorial Hospital
• Contact: Rapat Pittayanon, MD
• Phone: 66813132112
• Email: Rapat125[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: October 2017
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Intestinal Metaplasia
• Gastritis, Atrophic
• Metaplasia

Locations

Country	Name	City	State
Thailand	Rapat Pittayanon	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population	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	Up to 5 years	Yes

External Links

•   Ethic committee of KCMH