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临床试验/NCT00409396
NCT00409396已完成不适用

Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2006年11月1日最近更新:
适应症
干预措施

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

Experimental

Fecal calprotectin and urinary PGEm levels will be tested on all participants.

干预措施: Urinary PGEm level (Procedure)

1

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Schwartz

Principal Investigator

Vanderbilt University

研究点 (1)

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