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

NCT02197780 | Completed

• 1 other identifier: UMCG-2013N636
• Study Type: observational
• Target: 355
• Locations: 2 countries
• Sites: 19

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.

Conditions

Abdominal Pain; Rectal Bloodloss; Diarrhea; Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Irritable Bowel Syndrome

Keywords

Diagnostic accuracy; Fecal biomarker; Clinical Decision Rule; Cohort Study

Outcome Measures

Primary Outcomes (1)

• The difference in specificity between FC and S100A12 among the total number of non-IBD patients.

  6 months

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Scenario analysis with the test accuracy for a combination of FC and S100A12 in (sub)selection of patients.

  6 months

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Cisbio Bioassays: collaborator

Study Sites (19)

Sint Vincentiusziekenhuis

Antwerp, Belgium

Location

University Hospital Antwerpen

Antwerp, Belgium

Location

University Hospital Gent

Ghent, Belgium

Location

ZGT Almelo

Almelo, 7609 PP, Netherlands

Location

Wilhelmina Ziekenhuis

Assen, 9401 RK, Netherlands

Location

Deventer Ziekenhuis

Deventer, 7416 SE, Netherlands

Location

Ziekenhuis Nij Smellinghe

Drachten, 9292 NN, Netherlands

Location

Scheper Ziekenhuis

Emmen, 7824 AA, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7513 ER, Netherlands

Location

Admiraal de Ruyter ziekenhuis

Goes, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Martini Ziekenhuis

Groningen, 9728 NT, Netherlands

Location

Tjongerschans

Heerenveen, 8441 PW, Netherlands

Location

Bethesda Hospital

Hoogeveen, 7909 AA, Netherlands

Location

Medisch Centrum Leeuwarden (MCL)

Leeuwarden, 8934 AD, Netherlands

Location

Bravis ziekenhuis

Roosendaal, Netherlands

Location

Refaja Ziekenhuis

Stadskanaal, 9501 HE, Netherlands

Location

Ommelander Ziekenhuis Groep

Winschoten, 9671 CX, Netherlands

Location

Isala Kliniek

Zwolle, 8025 AB, Netherlands

Location

Related Publications (4)

• Van de Vijver E, Heida A, Ioannou S, Van Biervliet S, Hummel T, Yuksel Z, Gonera-de Jong G, Schulenberg R, Muller Kobold A, Verkade HJ, van Rheenen PF; CACATU CONSORTIUM. Test Strategies to Predict Inflammatory Bowel Disease Among Children With Nonbloody Diarrhea. Pediatrics. 2020 Aug;146(2):e20192235. doi: 10.1542/peds.2019-2235. Epub 2020 Jul 21.

  PMID: 32694147 DERIVED

• Heida A, Van de Vijver E, van Ravenzwaaij D, Van Biervliet S, Hummel TZ, Yuksel Z, Gonera-de Jong G, Schulenberg R, Muller Kobold A, van Rheenen PF; CACATU consortium. Predicting inflammatory bowel disease in children with abdominal pain and diarrhoea: calgranulin-C versus calprotectin stool tests. Arch Dis Child. 2018 Jun;103(6):565-571. doi: 10.1136/archdischild-2017-314081. Epub 2018 Mar 7.

  PMID: 29514815 DERIVED

• Heida A, Van de Vijver E, Muller Kobold A, van Rheenen P. Selecting children with suspected inflammatory bowel disease for endoscopy with the calgranulin C or calprotectin stool test: protocol of the CACATU study. BMJ Open. 2017 May 29;7(5):e015636. doi: 10.1136/bmjopen-2016-015636.

  PMID: 28554936 DERIVED

• Heida A, Dijkstra A, Dantuma SK, van Rheenen PF. A Cross-Sectional Study on the Perceptions and Practices of Teenagers With Inflammatory Bowel Disease About Repeated Stool Sampling. J Adolesc Health. 2016 Oct;59(4):479-81. doi: 10.1016/j.jadohealth.2016.06.009. Epub 2016 Aug 6.

  PMID: 27506279 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces

MeSH Terms

Conditions

Abdominal Pain; Diarrhea; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Colonic Diseases, Functional

Study Officials

• Patrick F van Rheenen, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

NL (16); BE (3)