Significance of Ficolin 2 in the Determination of Serological Activity in Chronic Inflammatory Bowel Disease

NCT01473927 | Completed

• 1 other identifier: 110/06
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 3

Brief Summary

Background Determining disease activity in IBD is sometimes difficult and, to be accurate, requires endoscopy. The serum marker CRP has not proven sufficiently valuable as a marker for IBD specific inflammation. As an alternative, so far fecal calprotectin appears to be more reliable and has shown a certain value as predictive marker. Our preliminary data now show, that the serum concentrations of ficolin-2 are significantly higher in CD patients with a HBI \>3. Ficolin-2 is a lectin and acute phase protein produced in the liver and, like MBL, can activate the lectin pathway of complement. Unlike MBL, deficiency for ficolin-2 was not detected in our patient cohort, nor could we find functional deficiencies for ficolin-2 (paper submitted). Study Aims The study is aimed to substantiate the data from our pilot study which shows that ficolin-2 is significantly increased in CD patients during inflammation. Therefore, the study will measure ficolin-2 concentrations in a sufficiently large patient group to obtain enough statistical power and to compare these results with the endoscopic disease score (SES-CD) and CRP and calprotectin values. Statistical analysis of the data will show us if ficolin-2 is a reliable and easy to obtain new marker for active inflammation in CD. Study Design Based on a power analysis 112 CD patients and 112 UC patients need to be analyzed. They will be recruited from Bern, Basel and Lausanne. Only patients with routine endoscopy will be included in the study and will be scored by SES-CD. Blood samples will be collected at the day of endoscopy. Stool sample will be collected within the same week of endoscopy. Calprotectin and CRP concentrations will be determined by routine diagnostics, ficolin-2 concentrations will be determined by ELISA in our laboratory. Finally, all data will be statistically analyzed.

Conditions

Crohn Disease

Keywords

Inflammatory bowel diseases; Crohn disease; Ficolin-2; C-Reactive Protein; Calprotectin; Inflammatory markers; SES-CD

Outcome Measures

Primary Outcomes (1)

• Ficolin-2 concentration in serum

  During endoscopy

Secondary Outcomes (2)

• CRP concentration in serum

  During endoscopy

• Calprotectin in stool sample

  One week before endoscopy up to one week after endoscopy

Study Arms (2)

1

Crohn's Disease patients

Other: Endoscopy

2

Ulcerative colitis patients

Other: Endoscopy

Interventions

Endoscopy OTHER

Only patients undergoing endoscopy for clinical reasons will be included in the study, i.e. no endoscopies will be performed solely for study reasons. For the purposes of our study, endoscopy serves to determine the degree of inflammation and no additional biopsies are taken. Blood for CRP and ficolin-2 analysis will be taken through the Venflon® installed for endoscopy.

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All CD and UC patients undergoing endoscopy for clinical reasons at one of the involved clinical centers.

You may qualify if:

• known IBD
• endoscopy for clinical reasons
• enrolled in the Swiss IBD cohort study

Sponsors & Collaborators

• University of Bern: lead
• University Hospital, Basel, Switzerland: collaborator
• University of Lausanne Hospitals: collaborator
• Swiss IBD Cohort Study: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Gastroenterology and Hepatology, Basel University Hospital

Basel, Canton of Basel-City, 4031, Switzerland

Location

DCR, Gastroenterology, Bern, University of Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Service de gastro-entérologie et hépatologie, CHUV Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Holmskov U, Thiel S, Jensenius JC. Collections and ficolins: humoral lectins of the innate immune defense. Annu Rev Immunol. 2003;21:547-78. doi: 10.1146/annurev.immunol.21.120601.140954. Epub 2001 Dec 19.

  PMID: 12524383 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum Stool

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Frank Seibold, Prof. Dr. med.

  Spital Tiefenau / Inselspital Bern

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 17, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

CH (3)