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Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD

NCT02197780 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 355

Last updated 2017-05-04

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Cisbio Bioassays

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Patrick F van Rheenen, MD PhD · University Medical Center Groningen

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02197780 on ClinicalTrials.gov