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

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

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.
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 Names:
  • 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 Names:
  • Syndecan-1

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
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
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

Meir Medical Center

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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