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Syndecan-1 a Surrogate Marker for IBD (syndecan1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01430039
First received: August 28, 2011
Last updated: December 4, 2012
Last verified: March 2012
  Purpose

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 Intervention
Inflammatory Bowel Diseases
Procedure: blood sample
Procedure: Blood sample - venous blood 10 ml.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Syndecan-1 as a Surrogate Marker for Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Elevated serum syndecan-1 levels as a bio marker for IBD [ Time Frame: one year ] [ Designated as safety issue: No ]
    elevated serum syndecan-1 levels in patients with IBD compared to control


Secondary Outcome Measures:
  • Serum syndecan-1 levels and disease severity Crohn's [ Time Frame: one year ] [ Designated as safety issue: No ]
    Relationship between clinical data CDAI in crohn's patients and serum syndecan-1 levels

  • Serum syndecan-1 levels and disease severity ulcerative colitis [ Time Frame: one year ] [ Designated as safety issue: No ]
    Relationship between clinical data UCAI ulcerative colitis patients and serum syndecan-1 levels

  • Serum syndecan-1 levels and C reactive protein(CRP) Crohn's [ Time Frame: one year ] [ Designated as safety issue: No ]
    Relationship between lab data CRP levels in crohn's patients and serum syndecan-1 levels

  • Serum syndecan-1 levels and C reactive protein(CRP) ulcerative colitis [ Time Frame: one year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 75
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430039

Contacts
Contact: Assaf Stein, Md 9727466893 assafstein@hotmail.com
Contact: Doron Yablakovic, Md

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: assafs stein, Md    097466893    assafstein@hotmail.com   
Contact: Dron Yablakovic, Md         
Principal Investigator: Assaf Stein, Md         
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
Study First Received: August 28, 2011
Last Updated: December 4, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 27, 2014