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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
Sponsor:
Information provided by (Responsible Party):
Ji Yong Ahn, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment
Gastric Cancer Other: No intervention

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 1178 participants
Observational Model: Case Control
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Gastric cancer
No intervention
Other: No intervention
No intervention will be needed.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Degree of decresed serum cholesterol levels in paitents with gastric neoplasm [ Time Frame: up to 24 months ]
    1. 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.
    2. 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
endoscopic biopsy specimen of gastric mucosa surgically resected specimen of stomach


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All subjects who visited the department of gastroenterology, surgery, or Healthcare Screening & Promotion Center at Asan Medical Center and diagnosed as gastric cancer
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Ji Yong Ahn, M.D., PhD. 8220147233144 ji110@hanmail.net

Locations
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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    ji110@hanmail.net   
Principal Investigator: Eun Jeong Gong, M.D.         
Sponsors and Collaborators
Asan Medical Center
Investigators
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Study Chair: Hwoon-Yong Jung, M.D., PhD. Asan Medical Center

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Responsible Party: Ji Yong Ahn, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02041312     History of Changes
Other Study ID Numbers: AMC-1312
KCHUGRFG1312 ( Other Grant/Funding Number: Korean J Helicobacter Up Gastrointest Res )
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ji Yong Ahn, Asan Medical Center:
Cholesterol
Gastric cancer
Stage

Additional relevant MeSH terms:
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Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases