跳至主要内容
临床试验/NCT01490541
NCT01490541Unknown不适用

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

King Chulalongkorn Memorial Hospital1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
280
试验地点
1
主要终点
The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients were diagnosed GIM
  • All patients have to sign the consent form

排除标准

  • Previous gastric surgery including gastrectomy and bypass surgery
  • Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
  • HIV infection
  • History of proton pump inhibitor use within 1 week
  • History of antibiotic use within 4 weeks

结局指标

主要结局

The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rapat Pittayanon, MD

Principle investigator

King Chulalongkorn Memorial Hospital

研究点 (1)

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