Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Urine for PGE-M levels
研究概览
简要总结
The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.
详细描述
The available clinical measures of Crohn's disease activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing inflammatory bowel disease (IBD) disease activity including erythrocyte sedimentation rate, C-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. What is needed is a simple, non-invasive, biologic measure of Crohn's disease.
Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Outpatient male or female 18 years or older
- •Confirmed diagnosis of Crohn's disease
- •Informed consent obtained
- •Able to give blood, urine and stool samples
- •Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care
排除标准
- •Unable to give consent
- •Ulcerative colitis
- •Does not meet inclusion criteria
结局指标
主要结局
Urine for PGE-M levels
时间窗: Day of colonoscopy procedure
次要结局
- Harvey-Bradshaw index disease activity score(Day of colonoscopy procedure)
- Blood for C-reactive protein (CRP) levels(Day 1)
- Routine colonoscopy for assessment of disease activity(1-3 weeks from consent)
- Stool for fecal calprotectin(Prior to colonoscopy procedure (before beginning bowel prep))
研究者
David Schwartz
Principal Investigator
Vanderbilt University Medical Center