Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD (CACATU)
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|ClinicalTrials.gov Identifier: NCT02197780|
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : May 4, 2017
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.
To determine whether the specificity of S100A12 is superior to the specificity of calprotectin without sacrificing sensitivity
Inclusion of the calgranulin C stool test will improve the specificity of the screening-strategy.
|Condition or disease|
|Abdominal Pain Rectal Bloodloss Diarrhea Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Irritable Bowel Syndrome|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||355 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Calprotectin or Calgranulin C-test Before Undergoing Endoscopy: a Prospective Diagnostic Accuracy Study Comparing Two Fecal Biomarkers for Pediatric IBD|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||April 2017|
- The difference in specificity between FC and S100A12 among the total number of non-IBD patients. [ Time Frame: 6 months ]
- The difference in sensitivity between FC and S100A12 among the total number of IBD patients. [ Time Frame: 6 months ]
- Diagnostic test accuracy characteristics for both FC and S100A12 [ Time Frame: 6 months ]Calculate sensitivity, specificity, positive predictive value, negative predictive value, area under ROC-curve, best cut-off point. The sensitivity, specificity, positive predictive value and negative predictive value will be presented with 1) a pre-specified cutoff value based on literature and 2) with the best cut-off points from this trial
- Scenario analysis with the test accuracy for a combination of FC and S100A12 in (sub)selection of patients. [ Time Frame: 6 months ]Scenario analysis with presentation of the number of true- and false positives and true- and false negatives for 1) only FC screening, 2) only S100A12 screening, 3) combination of FC and S100A12 screening, 4) combination of FC and S100A12 in sub-selection of patients with indeterminate result.
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197780
|Principal Investigator:||Patrick F van Rheenen, MD PhD||University Medical Center Groningen|