Calprotectin or Calgranulin C-test Before Undergoing Endoscopy: a Prospective Diagnostic Accuracy Study Comparing Two Fecal Biomarkers for Pediatric IBD
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
- 否
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
P.F. van Rheenen
Pediatric Gastroenterologist
University Medical Center Groningen
