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Syndecan-1 a Surrogate Marker for IBD (syndecan1)

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ClinicalTrials.gov Identifier: NCT01430039
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Procedure: blood sample Procedure: Blood sample - venous blood 10 ml.

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 Design

Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Syndecan-1 as a Surrogate Marker for Inflammatory Bowel Disease
Study Start Date : October 2011
Primary Completion Date : April 2015
Study Completion Date : April 2015
Groups and Cohorts

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.
Procedure: Blood sample - venous blood 10 ml.
venous blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1
Other Name: Syndecan-1
No disease
Healthy subjects with no known inflammatory disease. For basal serum levels of syndecan 1
Procedure: blood sample
Blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1
Other Name: Syndecan-1


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Biospecimen Retention:   None Retained
Venous blood sample for syndecan-1 levels, blood count, CRP levels,serum albumin and total protein

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal population, having no known inflammatory disease
Criteria

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
Contacts and Locations

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): NCT01430039


Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Assaf Stein, Md resident
More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01430039     History of Changes
Other Study ID Numbers: 03.09.11.01
31.08.11 ( Registry Identifier: syndecan-1 and inflammatory bowel disease )
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: March 2012

Keywords provided by Meir Medical Center:
Crohn's disease
ulcerative colitis
Syndecan-1

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis