Serum Cholesterol and Gastric Neoplasm

Gastric Cancer Clinical Trial

— SCGN  

Official title:

Serum Cholesterol and Gastric Neoplasm: Nested Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02041312
• Other study ID #: AMC-1312
• Secondary ID: KCHUGRFG1312
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2014
• Last updated: December 4, 2016
• Start date: February 2014
• Est. completion date: June 2019

Study information

• Verified date: December 2016
• Source: Asan Medical Center
• Contact: Ji Yong Ahn, M.D., PhD.
• Phone: 8220147233144
• Email: ji110[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1178
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Neoplasms
• Stomach Neoplasms

Intervention

Other:
• No intervention
No intervention will be needed.

Locations

Country	Name	City	State
Korea, Republic of	Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterol level in paitents with and withoutgastric neoplasm	Serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins will be checked and compared in paitents with and withoutgastric neoplasm.	up to 24 months	Yes
Secondary	Degree of decresed serum cholesterol levels in paitents with gastric neoplasm	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.	up to 24 months	Yes