Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Urine for PGEm Levels
研究概览
简要总结
The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.
详细描述
The available clinical measures of ulcerative colitis 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 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 UC 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. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 ulcerative colitis
- •Informed consent obtained
- •Able to give blood, urine and stool samples
- •Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care
排除标准
- •Unable to give consent
- •Crohn's disease
- •Does not meet inclusion criteria
研究组 & 干预措施
1
Fecal calprotectin and urinary PGEm levels will be tested on all participants.
干预措施: Urinary PGEm level (Procedure)
1
Fecal calprotectin and urinary PGEm levels will be tested on all participants.
干预措施: fecal calprotectin (Procedure)
结局指标
主要结局
Urine for PGEm Levels
时间窗: Day of colonoscopy procedure
次要结局
- Blood for CRP(Day 1)
- Stool for fecal calprotectin(At least 2 days before colonoscopy procedure (prior to bowel prep))
- MAYO disease activity score(Day of colonoscopy procedure)
- Routine colonoscopy for assessment of disease activity(1-3 weeks after consent)
研究者
David Schwartz
Principal Investigator
Vanderbilt University
