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

June 22, 2012 updated by: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All GIM patients in KCMH whose diagnosed from 1997 to 2005, at least 280.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Gastric intestinal metaplasia patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Chulalongkorn Memorial Hospital

Investigators

  • Study Director: Rungsun Rerknimitr, Professor, King Chulalongkorn Memorial Hospital
  • Principal Investigator: Rapat Pittayanon, MD, King Chulalongkron Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 9, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Estimate)

June 25, 2012

Last Update Submitted That Met QC Criteria

June 22, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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