ClinicalTrials.gov
ClinicalTrials.gov 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.
ClinicalTrials.gov Identifier: NCT02197780
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
Cisbio Bioassays
Information provided by (Responsible Party):
P.F. van Rheenen, University Medical Center Groningen

Brief 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.


Condition or disease
Abdominal Pain Rectal Bloodloss Diarrhea Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Irritable Bowel Syndrome

  Show Detailed Description

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
U.S. FDA Resources




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
Feces


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.


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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02197780


Locations
Belgium
Sint Vincentiusziekenhuis
Antwerpen, Belgium
University Hospital Antwerpen
Antwerpen, Belgium
University Hospital Gent
Gent, Belgium
Netherlands
ZGT Almelo
Almelo, Netherlands, 7609 PP
Wilhelmina Ziekenhuis
Assen, Netherlands, 9401 RK
Deventer Ziekenhuis
Deventer, Netherlands, 7416 SE
Ziekenhuis Nij Smellinghe
Drachten, Netherlands, 9292 NN
Scheper Ziekenhuis
Emmen, Netherlands, 7824 AA
Medisch Spectrum Twente
Enschede, Netherlands, 7513 ER
Admiraal de Ruyter ziekenhuis
Goes, Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Martini Ziekenhuis
Groningen, Netherlands, 9728 NT
Tjongerschans
Heerenveen, Netherlands, 8441 PW
Bethesda Hospital
Hoogeveen, Netherlands, 7909 AA
Medisch Centrum Leeuwarden (MCL)
Leeuwarden, Netherlands, 8934 AD
Bravis ziekenhuis
Roosendaal, Netherlands
Refaja Ziekenhuis
Stadskanaal, Netherlands, 9501 HE
Ommelander Ziekenhuis Groep
Winschoten, Netherlands, 9671 CX
Isala Kliniek
Zwolle, Netherlands, 8025 AB
Sponsors and Collaborators
University Medical Center Groningen
Cisbio Bioassays
Investigators
Principal Investigator: Patrick F van Rheenen, MD PhD University Medical Center Groningen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: P.F. van Rheenen, Pediatric Gastroenterologist, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02197780     History of Changes
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:
Crohn Disease
Colitis, Ulcerative
Diarrhea
Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Abdominal Pain
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Pain
Neurologic Manifestations
Nervous System Diseases