The Comparison Between That Expression Pattern and Disease Activity of Variable Biomarkers in Inflammatory Bowel Disease Patients and General Control Group. Multicenter, Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- measurement of blood-based biomarkers to predict disease activity 1
研究概览
简要总结
The aims of this study is to investigate a blood-based biomarker that can replace endoscopy in patients with inflammatory bowel disease. For this purpose, blood sample of patients wiht inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same time the endoscopy is performed, stored after centrifugation, and analyzed accordingly. Selected biomarkers from the blood sample were investigated to compare those of patients with inflammatory bowel disease and those of general controls. Males and females over the age of 19 participated in the study and are excluded if they have chronic kidney disease or blood clotting disease. The outcome is a find of a blood-based biomarker that best reflects a disease activity.
详细描述
Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs in the intestine. It usually refers to ulcerative colitis and Crohn's disease, which are idiopathic inflammatory bowel diseases. While it had been known to be a common disease in the western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has rapidly increased in Korea as well. Endoscopic examination is a gold standard in order to determine the activity of inflammatory bowel disease, but it is hardly performed due to the cost and time of a test. Therefore, it is necessary to find a blood-based biomarker that replaces endoscopy. The objective of the study is to identify a new inflammatory marker that replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease with those of general controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •people who receive colonoscopy
- •people who sign the consent
- •having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome
排除标准
- •those aged over 75 years
- •the disabled
- •pregnant women
- •chronic renal diseases (CLcr <50ml/min)
- •blood coagulopathy (PT INR > 1.5, aPTT > 45 seconds, or platelet count < 50,000/mm)
- •people who refuse to sign the consent
结局指标
主要结局
measurement of blood-based biomarkers to predict disease activity 1
时间窗: within 12 weeks of the blood sampling
REG3 alpha (ng/mL)
measurement of blood-based biomarkers to predict disease activity 2
时间窗: within 12 weeks of the blood sampling
hs-CRP (mg/dL)
measurement of blood-based biomarkers to predict disease activity 3
时间窗: within 12 weeks of the blood sampling
serum calprotectin (ng/mL)
次要结局
- Gender (M/F)(at the time of study enrolled)
- Age (years)(at the time of study enrolled)
- disease onset (years)(at the time of study enrolled)
- disease duration (months)(at the time of study enrolled)
研究者
Bo-In Lee
Professor, MD, PhD.
Seoul St. Mary's Hospital