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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014