Syndecan-1 a Surrogate Marker for IBD (syndecan1)
April 7, 2015 updated by: Meir Medical Center
Syndecan-1 as a Surrogate Marker for Inflammatory Bowel Disease
Syndecan-1 is a protein on the surface intestinal cells. previous studies proved low levels of mucosal syndecan-1 levels on the surface of intestinal cells is patients with acute and chronic inflammation due to inflammatory bowel disease.
this protein might shed from cell surface to the serum. The investigators wish to prove that elevated serum levels of syndecan-1 may be predictive of disease presence, extent and severity, that buy taking a simple blood sample from patients diagnosed with inflammatory bowel disease and comparing to normal subjects and to other markers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One of the main hypothesis for the etiology of Inflammatory bowel disease (IBD) is an inappropriate and ongoing activation of the mucosal immune system in response to the presence of normal luminal flora.
This aberrant response is most likely facilitated by defects in both the barrier function and the mucosal immune system of the intestinal epithelium.
Syndecans are a class proteoglycans that take part in both cell adhesion and growth factor binding.
Of the four known syndecan core proteins, syndecan-1 (CD138) and one of the best studied of this group and is also the relevant to the this study as it is expressed on the basolateral surface of columnar epithelial cells of the colon.
Syndecan-1 functions as an integral membrane protein that participates in cell proliferation, cell migration and cell matrix interactions in the GI tract.
Evidence for a reduction of syndecan-1 expression in the regenerating epithelium that overlies inflamed tissue was reported in both acute and chronic inflammation.
This protein that is lost from the inflamed mucosal membrane might shed to the serum.
Elevated serum levels of syndecan-1 may be predictive of disease presence and extent.
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kfar Saba, Israel
- Meir Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Normal population, having no known inflammatory disease
Description
Inclusion Criteria:
- informed consent
- no other concurrent inflammatory disease
- formal diagnosis of inflammatory bowel disease i.e Crohn's disease, Ulcerative colitis
Exclusion Criteria:
- pregnancy
- fever at time of sample taking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Crohn's, ulcerative colitis
Patients with diagnosed with Crohn's disease or ulcerative colitis who agreed to participate in the study and singed informed consent and answered a Crohn's disease activity index questioner for Crohn's disease or the ulcerative colitis activity index questioner for ulcerative colitis.
|
venous blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1
Other Names:
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No disease
Healthy subjects with no known inflammatory disease.
For basal serum levels of syndecan 1
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Blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Elevated serum syndecan-1 levels as a bio marker for IBD
Time Frame: one year
|
elevated serum syndecan-1 levels in patients with IBD compared to control
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum syndecan-1 levels and disease severity Crohn's
Time Frame: one year
|
Relationship between clinical data CDAI in crohn's patients and serum syndecan-1 levels
|
one year
|
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Serum syndecan-1 levels and disease severity ulcerative colitis
Time Frame: one year
|
Relationship between clinical data UCAI ulcerative colitis patients and serum syndecan-1 levels
|
one year
|
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Serum syndecan-1 levels and C reactive protein(CRP) Crohn's
Time Frame: one year
|
Relationship between lab data CRP levels in crohn's patients and serum syndecan-1 levels
|
one year
|
|
Serum syndecan-1 levels and C reactive protein(CRP) ulcerative colitis
Time Frame: one year
|
Relationship between serum CRP levels and serum syndecan-1 levels in patients with ulcerative colitis
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Assaf Stein, Md, Resident
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yablecovitch D, Shabat-Simon M, Aharoni R, Eilam R, Brenner O, Arnon R. Beneficial effect of glatiramer acetate treatment on syndecan-1 expression in dextran sodium sulfate colitis. J Pharmacol Exp Ther. 2011 May;337(2):391-9. doi: 10.1124/jpet.110.174276. Epub 2011 Feb 10.
- Bartlett AH, Hayashida K, Park PW. Molecular and cellular mechanisms of syndecans in tissue injury and inflammation. Mol Cells. 2007 Oct 31;24(2):153-66.
- Bode L, Salvestrini C, Park PW, Li JP, Esko JD, Yamaguchi Y, Murch S, Freeze HH. Heparan sulfate and syndecan-1 are essential in maintaining murine and human intestinal epithelial barrier function. J Clin Invest. 2008 Jan;118(1):229-38. doi: 10.1172/JCI32335.
- Carey DJ. Syndecans: multifunctional cell-surface co-receptors. Biochem J. 1997 Oct 1;327 ( Pt 1)(Pt 1):1-16. doi: 10.1042/bj3270001.
- Seidel C, Sundan A, Hjorth M, Turesson I, Dahl IM, Abildgaard N, Waage A, Borset M. Serum syndecan-1: a new independent prognostic marker in multiple myeloma. Blood. 2000 Jan 15;95(2):388-92. Erratum In: Blood 2000 Apr 1;95(7):2197.
- Principi M, Day R, Marangi S, Burattini O, De Francesco V, Ingrosso M, Pisani A, Panella C, Forbes A, Di Leo A, Francavilla A, Ierardi E. Differential immunohistochemical expression of syndecan-1 and tumor necrosis factor alpha in colonic mucosa of patients with Crohn's disease. Immunopharmacol Immunotoxicol. 2006;28(2):185-95. doi: 10.1080/08923970600815048.
- Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.
- Gaffney PR, O'Leary JJ, Doyle CT, Gaffney A, Hogan J, Smew F, Annis P. Response to heparin in patients with ulcerative colitis. Lancet. 1991 Jan 26;337(8735):238-9. doi: 10.1016/0140-6736(91)92201-c. No abstract available.
- Day RM, Mitchell TJ, Knight SC, Forbes A. Regulation of epithelial syndecan-1 expression by inflammatory cytokines. Cytokine. 2003 Mar 7;21(5):224-33. doi: 10.1016/s1043-4666(03)00091-7.
- Day R, Ilyas M, Daszak P, Talbot I, Forbes A. Expression of syndecan-1 in inflammatory bowel disease and a possible mechanism of heparin therapy. Dig Dis Sci. 1999 Dec;44(12):2508-15. doi: 10.1023/a:1026647308089.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
August 28, 2011
First Submitted That Met QC Criteria
September 6, 2011
First Posted (Estimate)
September 7, 2011
Study Record Updates
Last Update Posted (Estimate)
April 8, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03.09.11.01
- 31.08.11 (Registry Identifier: syndecan-1 and inflammatory bowel disease)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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