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临床试验/NCT02041312
NCT02041312Unknown不适用

Serum Cholesterol and Gastric Neoplasm: Nested Case-control Study

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 1,178 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,178
试验地点
1
主要终点
Cholesterol level in paitents with and withoutgastric neoplasm

研究概览

简要总结

Investigators have a plan to conduct nested case-control study to investigate the association between serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins and gastric neoplasm. In addition, further analyses were performed to evaluate the possible role of the serum cholesterol as a predictor for the differentiation and prognosis of gastric neoplasm.

详细描述

Although its incidence has declined, gastric cancer remains one of the most common causes of cancer morbidity and mortality worldwide.Since the stage of gastric cancer at the time of detection correlates with prognosis, secondary prevention is important. Screening of asymptomatic individuals for gastric cancer has been shown to increase the detection of early gastric cancer (EGC), which has a 5-year overall survival (OS) rate exceeding 90%.

Gastric carcinogenesis is a multi-factorial process that includes environmental, socioeconomic, and lifestyle factors. Many of risk factors, including dietary factors, chronic atrophic gastritis, intestinal metaplasia, and H. pylori infection, alcohol consumption, and aspirin have been investigated. Although the specific correlation between serum cholesterol and gastric cancer is not fully understood, inverse relationships have been observed between serum total cholesterol (TC) levels and cancer, and recent analyses of randomized controlled trials showed significant inverse associations between high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) and the risk of incident cancers. Lower lipoprotein cholesterol in cancer patients may be due to the enhanced activity of the lipoprotein cholesterol receptor pathway and to the increased demand for cholesterol during tumor development and lymphatic spread. Some suggested that the preexisting tumor might have resulted in low serum cholesterol, which is called "preclinical cancer effect" or "unsuspected sickness". In another study, LDL-C has been reported to affect host immune system cells.

In our previous study, investigators found that serum HDL-C and LDL-C levels were associated with the risk, resectability, and prognosis of gastric cancer. There are several cohort studies reported that low serum cholesterol levels are associated with incident cancer, including gastric cancer. However, most studies regarding the serum cholesterol and gastric cancer investigated gastrectomized patients, and showed the association between low serum cholesterol levels and lymph node metastasis or submucosal invasion. Furthermore, there are only few studies evaluated the association between LDL-C of apolipoproteins and gastric cancer. Therefore investigators conducted nested case-control study to investigate the association between serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins and gastric neoplasm. In addition, further analyses were performed to evaluate the possible role of the serum cholesterol as a predictor for the differentiation and prognosis of gastric neoplasm.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All subjects who visited the department of gastroenterology, surgery, or Healthcare Screening & Promotion Center at Asan Medical Center and diagnosed as gastric cancer

排除标准

  • Subjects who has history about drug for cholesterol, diabetes, liver disease, and/or thyroid disease.
  • Subjects who do not want to be enrolled this study

结局指标

主要结局

Cholesterol level in paitents with and withoutgastric neoplasm

时间窗: up to 24 months

Serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins will be checked and compared in paitents with and withoutgastric neoplasm.

次要结局

  • Degree of decresed serum cholesterol levels in paitents with gastric neoplasm(up to 24 months)

研究者

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

Ji Yong Ahn

Professor

Asan Medical Center

研究点 (1)

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