Serum Cholesterol and Gastric Neoplasm (SCGN)
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|ClinicalTrials.gov Identifier: NCT02041312|
Recruitment Status : Unknown
Verified December 2016 by Ji Yong Ahn, Asan Medical Center.
Recruitment status was: Recruiting
First Posted : January 22, 2014
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment|
|Gastric Cancer||Other: No intervention|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1178 participants|
|Observational Model:||Case Control|
|Official Title:||Serum Cholesterol and Gastric Neoplasm: Nested Case-control Study|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
Other: No intervention
No intervention will be needed.
- Cholesterol level in paitents with and withoutgastric neoplasm [ Time Frame: 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.
- Degree of decresed serum cholesterol levels in paitents with gastric neoplasm [ Time Frame: up to 24 months ]
- Degree of decresed serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins in patients with gastric neoplasm compare to the patients without gastric neoplasm.
- Degree of decresed serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins in patients with gastric neoplasm according to the stage of gastric neoplasm.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041312
|Contact: Ji Yong Ahn, M.D., PhD.||firstname.lastname@example.org|
|Korea, Republic of|
|Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Ji Yong Ahn, M.D., PhD. 8221062413144 email@example.com|
|Principal Investigator: Eun Jeong Gong, M.D.|
|Study Chair:||Hwoon-Yong Jung, M.D., PhD.||Asan Medical Center|