Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02197780
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : May 4, 2017
Cisbio Bioassays
Information provided by (Responsible Party):
P.F. van Rheenen, University Medical Center Groningen

Brief Summary:


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

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 355 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Primary Outcome Measures :
  1. The difference in specificity between FC and S100A12 among the total number of non-IBD patients. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The difference in sensitivity between FC and S100A12 among the total number of IBD patients. [ Time Frame: 6 months ]
  2. 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

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible for inclusion are consecutive children and teenagers who consult their pediatrician and have gastro-intestinal symptoms suggestive of IBD. Participating centers are located in the Northern and Southern region of the Netherlands and the Flemish-speaking region of Belgium.

Eligible patients are those aged between 6 and 18 years with at least one of the following criteria:

  • Persistent diarrhea (at least 4 wks)
  • Recurrent abdominal pain with diarrhea (at least 2 episodes in 6 months)
  • Rectal bloodloss
  • Peri-anal disease

OR at least two of the following criteria:

  • Involuntary weight loss
  • First degree family member with IBD
  • Anemia (HB < -2 SD for age and gender)
  • Increased marker of inflammation (ESR >20 mm/hour or CRP >10 mg/L)
  • Extra-intestinal symptoms (erythema nodosum, arthritis, uveitis, thromboembolism, aphtous ulcera)

We did not define any exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02197780

Show Show 19 study locations
Sponsors and Collaborators
University Medical Center Groningen
Cisbio Bioassays
Layout table for investigator information
Principal Investigator: Patrick F van Rheenen, MD PhD University Medical Center Groningen
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: P.F. van Rheenen, Pediatric Gastroenterologist, University Medical Center Groningen Identifier: NCT02197780    
Other Study ID Numbers: UMCG-2013N636
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by P.F. van Rheenen, University Medical Center Groningen:
Diagnostic accuracy
Fecal biomarker
Clinical Decision Rule
Cohort Study
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Abdominal Pain
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Neurologic Manifestations