Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The expression level of multiple markers associated with IBD activity or prognosis
研究概览
简要总结
A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease
详细描述
Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory disease composed of two types: Crohn's disease (CD) and ulcerative colitis (UC). It is difficult to cure the IBD completely and patients with clinical or endoscopic remission can worsen again. Therefore, predicting the prognosis of patients with IBD is still challenging.
Endoscopic biopsied samples and blood samples from IBD patients and non-IBD controls have been collected and the expression levels of multiple markers which are associated with disease activity and severity will be assessed. The correlation between expression levels of multiple markers and prognosis will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •control group: Patients who do not have colitis, cancer, and advanced polyp (the number of polyps ≥ 3, the size of polyps ≥ 1cm, high-grade adenoma, villous adenoma)
- •TNF-α inhibitor-naive IBD group: IBD patients who do not have a history of TNF-α inhibitor treatment
- •TNF-α inhibitor-treated IBD group: IBD patients who are treated with TNF-α inhibitor
排除标准
- •Age under 18 years
- •Patients who were treated with antibiotics or probiotics within the last 3 months
研究组 & 干预措施
Control group
Patients who are not diagnosed with inflammatory bowel disease and have colitis.
干预措施: Endoscopic biopsy (Other)
TNF-alpha Inhibitor-naive IBD group
Patients who are diagnosed with inflammatory bowel disease but do not have a history of TNF-a inhibitor treatment.
干预措施: Endoscopic biopsy (Other)
TNF-alpha Inhibitor-treated IBD group
Patients who are diagnosed with inflammatory bowel disease and have a history of TNF-a inhibitor treatment.
干预措施: Endoscopic biopsy (Other)
结局指标
主要结局
The expression level of multiple markers associated with IBD activity or prognosis
时间窗: baseline (at the time of enrollment)
The expression level of multiple markers was evaluated through RT-qPCR using endoscopically biopsied samples or blood samples. Markers include TGF-b, SLUG, SNAIL, E-cadherin, vimentin, OLFM4, LGR5, a-SMA, FSP1, IL-17A, IL-23, TGF-b, IL-6, IFN-r, IL-1b, FOXP3, PD-1, CD68, PAD4, COL3A1, TIMP3, LOX, ACTA2, ITGB6, CAV-1 etc.
次要结局
- The change of expression level of multiple markers associated with IBD activity or prognosis(Every 2 years. The examination will be suspended when treatment was ended.)
研究者
Nayoung Kim
professor
Seoul National University Bundang Hospital