跳至主要内容
临床试验/NCT02197780
NCT02197780已完成不适用

Calprotectin or Calgranulin C-test Before Undergoing Endoscopy: a Prospective Diagnostic Accuracy Study Comparing Two Fecal Biomarkers for Pediatric IBD

University Medical Center Groningen19 个研究点 分布在 2 个国家目标入组 355 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
355
试验地点
19
主要终点
The difference in specificity between FC and S100A12 among the total number of non-IBD patients.

研究概览

简要总结

RATIONALE:

A substantial proportion of children and teenagers with suspected inflammatory bowel disease (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical decision rule that included a calprotectin stool test to discern which patients require further investigations. The accuracy of this diagnostic strategy is 88.5% with a low risk of missing IBD cases. Although the number of negative endoscopies was reduced after introduction of this strategy, still 22% of the referred children and teenagers underwent an unnecessary invasive test. S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by activated neutrophils and this stool marker may be more IBD-specific than calprotectin.

OBJECTIVE:

To determine whether the specificity of S100A12 is superior to the specificity of calprotectin without sacrificing sensitivity

HYPOTHESIS:

Inclusion of the calgranulin C stool test will improve the specificity of the screening-strategy.

详细描述

DESIGN:

A prospective diagnostic accuracy study in several outpatient clinics for general paediatrics and several tertiary care hospitals in the Netherlands and Belgium.

STUDY POPULATION:

Eligible for inclusion are consecutive children and teenagers between 6 and 18 years who consult their pediatrician and have gastro-intestinal symptoms suggestive of IBD.

INTERVENTION:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The difference in specificity between FC and S100A12 among the total number of non-IBD patients.

时间窗: 6 months

次要结局

  • The difference in sensitivity between FC and S100A12 among the total number of IBD patients.(6 months)
  • Diagnostic test accuracy characteristics for both FC and S100A12(6 months)

研究者

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

P.F. van Rheenen

Pediatric Gastroenterologist

University Medical Center Groningen

研究点 (19)

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