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

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ClinicalTrials.gov Identifier: NCT01490541
Recruitment Status : Unknown
Verified June 2012 by Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 13, 2011
Last Update Posted : June 25, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

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


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.

Condition or disease
Gastric Intestinal Metaplasia

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 Design

Study Type : Observational
Estimated Enrollment : 280 participants
Time Perspective: Prospective
Study Start Date : October 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Groups and Cohorts

Gastric intestinal metaplasia patient

Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All GIM patients in KCMH whose diagnosed from 1997 to 2005, at least 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490541

Contact: Rapat Pittayanon, MD 66813132112 Rapat125@gmail.com
Contact: Nuttaphat Namjud, M.Sc. 66894971957 ampere_nut@hotmail.com

Rapat Pittayanon Recruiting
Bangkok, Thailand, 10330
Contact: Rapat Pittayanon, MD    66813132112    rapat125@gmail.com   
Contact: Nuttapaht Namjud, M.Sc    66894971957    ampere_nut@hotmail.com   
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Study Director: Rungsun Rerknimitr, Professor King Chulalongkorn Memorial Hospital
Principal Investigator: Rapat Pittayanon, MD King Chulalongkron Memorial Hospital
More Information

Additional Information:
Responsible Party: Rapat Pittayanon, MD, Principle investigator, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT01490541     History of Changes
Other Study ID Numbers: RP003
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012

Keywords provided by Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital:
Gastric intestinal metaplasia

Additional relevant MeSH terms:
Pathologic Processes