Identify Specific PBMC miRNAs as Biomarkers for IBD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
To find high sensitivity and specificity biomarkers to better diagnose and monitor progression of inflammatory bowel disease (IBD). In this study, we try to find miRNAs that can used to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and healthy controls. And we further validate these miRNAs in a larger population to assess their function as biomarkers.
详细描述
Incidence of inflammatory bowel disease (IBD) has been rising in the past decades. However, diagnosis and differential diagnosis of IBD still lack gold standard. To diagnose IBD, physicians need to combine clinical manifestation, lab results, image examination, endoscopy examination and pathology. After diagnosis, patients still need to monitor their disease progression. The most accurate way is to do endoscopy examination, however, endoscopy examination is an invasive, expensive and uncomfortable procedure. At present, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and fecal calprotectin are used as main noninvasive biomarkers to monitor progression routinely. But their specificities are still unsatisfactory. So, it's urgent to find high sensitivity and specificity biomarkers to better diagnose and monitor progression of IBD. In this study, we try to find miRNAs that can used to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and healthy controls. And we further validate these miRNAs in a larger population to assess their function as biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 75 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as Crohn's disease (CD) or ulcerative colitis (UC) according to World Health Organization (WHO) criteria
- •Vital signs are stable
排除标准
- •Refuse to sign consent
- •Refuse to do examination to assess their disease progression
- •CD patients only upper gastrointestinal tract (GI) is involved (L4)
- •Had colectomy or in artificial opening status
- •Have other autoimmune comorbidity
- •Had severe infection within a week
- •Had surgery within a month
- •Have malignant tumor
- •Pregnancy or lactation
结局指标
主要结局
Crohn's Disease Activity Index (CDAI)
时间窗: 2 months
Crohn's Disease Activity Index (CDAI) has been developed to assess whether or not the pathology of Crohn's disease is progressing. The index is the sum of 8 components, to each of which is assigned a specific weight. \<150 suggests remission, 151-219 suggests mild activity, 220-450 suggests moderate activity, \>450 suggests severe activity
Mayo Score
时间窗: 2 months
The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation and Physician's global assessment. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). 0-2 suggests remission, 3-5 suggests mild activity,6-10 suggests moderate activity, \>10 suggests severe activity
次要结局
未报告次要终点
