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

This study is currently recruiting participants.
Verified June 2012 by King Chulalongkorn Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01490541
First received: December 5, 2011
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
Gastric Intestinal Metaplasia

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King Chulalongkorn Memorial Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 280
Study Start Date: October 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gastric intestinal metaplasia patient

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

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490541

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

Locations
Thailand
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
Investigators
Study Director: Rungsun Rerknimitr, Professor King Chulalongkorn Memorial Hospital
Principal Investigator: Rapat Pittayanon, MD King Chulalongkron Memorial Hospital
  More Information

Additional Information:
Ethic committee of KCMH  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Rapat Pittayanon, MD, Principle investigator, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT01490541     History of Changes
Other Study ID Numbers: RP003
Study First Received: December 5, 2011
Last Updated: June 22, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by King Chulalongkorn Memorial Hospital:
Gastric intestinal metaplasia

Additional relevant MeSH terms:
Metaplasia
Gastritis, Atrophic
Pathologic Processes
Gastritis
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 19, 2013