- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02041312
Serum Cholesterol and Gastric Neoplasm (SCGN)
Serum Cholesterol and Gastric Neoplasm: Nested Case-control Study
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Seoul, Korea, Republiken av
- Rekrytering
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
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Kontakt:
- Ji Yong Ahn, M.D., PhD.
- Telefonnummer: 8221062413144
- E-post: ji110@hanmail.net
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Huvudutredare:
- Eun Jeong Gong, M.D.
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Gastric cancer
No intervention
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Inget ingripande kommer att behövas.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Cholesterol level in paitents with and withoutgastric neoplasm
Tidsram: up to 24 months
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Serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins will be checked and compared in paitents with and withoutgastric neoplasm.
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up to 24 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Degree of decresed serum cholesterol levels in paitents with gastric neoplasm
Tidsram: up to 24 months
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up to 24 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Hwoon-Yong Jung, M.D., PhD., Asan Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AMC-1312
- KCHUGRFG1312 (Annat bidrag/finansieringsnummer: Korean J Helicobacter Up Gastrointest Res)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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