Syndecan-1 a Surrogate Marker for IBD (syndecan1)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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 |
Normal population, having no known inflammatory disease
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| Contact: Assaf Stein, Md | 9727466893 | assafstein@hotmail.com |
| Contact: Doron Yablakovic, Md |
| 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 | |
| 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 Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013