Significance of Ficolin 2 in the Determination of Serological Activity in Chronic Inflammatory Bowel Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Crohn Disease |
Other: Endoscopy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Significance of Ficolin 2 in the Determination of Serological Activity in Chronic Inflammatory Bowel Disease |
- Ficolin-2 concentration in serum [ Time Frame: During endoscopy ] [ Designated as safety issue: No ]
- CRP concentration in serum [ Time Frame: During endoscopy ] [ Designated as safety issue: No ]
- Calprotectin in stool sample [ Time Frame: One week before endoscopy up to one week after endoscopy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum Stool
| Estimated Enrollment: | 224 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Crohn's Disease patients
|
Other: Endoscopy
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.
|
|
2
Ulcerative colitis patients
|
Other: Endoscopy
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
All CD and UC patients undergoing endoscopy for clinical reasons at one of the involved clinical centers.
Inclusion Criteria:
- known IBD
- endoscopy for clinical reasons
- enrolled in the Swiss IBD cohort study
Exclusion Criteria
Contacts and Locations| Switzerland | |
| Gastroenterology and Hepatology, Basel University Hospital | |
| Basel, Basel Stadt, Switzerland, 4031 | |
| Service de gastro-entérologie et hépatologie, CHUV Lausanne | |
| Lausanne, Vaud, Switzerland, 1011 | |
| DCR, Gastroenterology, Bern, University of Bern | |
| Bern, Switzerland, 3010 | |
| Study Director: | Frank Seibold, Prof. Dr. med. | Spital Tiefenau / Inselspital Bern |
More Information
Publications:
| Responsible Party: | Seibold Prof. Dr. med., Spital Tiefenau Bern / Inselspital Bern |
| ClinicalTrials.gov Identifier: | NCT01473927 History of Changes |
| Other Study ID Numbers: | 110/06 |
| Study First Received: | November 3, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University of Bern:
|
Inflammatory bowel diseases Crohn disease Ficolin-2 C-Reactive Protein |
Calprotectin Inflammatory markers SES-CD |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Intestinal Diseases |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013