NCT01430039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

March 1, 2012

Enrollment Period

3.5 years

First QC Date

August 28, 2011

Last Update Submit

April 7, 2015

Conditions

Inflammatory Bowel Diseases

Keywords

Crohn's diseaseulcerative colitisSyndecan-1

Outcome Measures

Primary Outcomes (1)

  • Elevated serum syndecan-1 levels as a bio marker for IBD

    elevated serum syndecan-1 levels in patients with IBD compared to control

    one year

Secondary Outcomes (4)

  • Serum syndecan-1 levels and disease severity Crohn's

    one year

  • Serum syndecan-1 levels and disease severity ulcerative colitis

    one year

  • Serum syndecan-1 levels and C reactive protein(CRP) Crohn's

    one year

  • Serum syndecan-1 levels and C reactive protein(CRP) ulcerative colitis

    one year

Study Arms (2)

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.

No disease

Healthy subjects with no known inflammatory disease. For basal serum levels of syndecan 1

Procedure: blood sample

Interventions

blood samplePROCEDURE

Blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1

Also known as: Syndecan-1
No disease
Blood sample - venous blood 10 ml.PROCEDURE

venous blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1

Also known as: Syndecan-1
Crohn's, ulcerative colitis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Normal population, having no known inflammatory disease

You may qualify if:

  • informed consent
  • no other concurrent inflammatory disease
  • formal diagnosis of inflammatory bowel disease i.e Crohn's disease, Ulcerative colitis

You may not qualify if:

  • pregnancy
  • fever at time of sample taking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Related Publications (10)

  • 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.

    PMID: 21310817BACKGROUND

  • 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.

    PMID: 17978567BACKGROUND

  • 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.

    PMID: 18064305BACKGROUND

  • Carey DJ. Syndecans: multifunctional cell-surface co-receptors. Biochem J. 1997 Oct 1;327 ( Pt 1)(Pt 1):1-16. doi: 10.1042/bj3270001.

    PMID: 9355727BACKGROUND

  • 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.

    PMID: 10627439BACKGROUND

  • 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.

    PMID: 16873088BACKGROUND

  • Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.

    PMID: 12665470BACKGROUND

  • 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.

    PMID: 1670865BACKGROUND

  • 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.

    PMID: 12824007BACKGROUND

  • 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.

    PMID: 10630505BACKGROUND

Biospecimen

Retention: NONE RETAINED

Venous blood sample for syndecan-1 levels, blood count, CRP levels,serum albumin and total protein

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Interventions

Blood Specimen CollectionSyndecan-1

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesSyndecansMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesHeparan Sulfate ProteoglycansProteoglycansProteinsAmino Acids, Peptides, and ProteinsMembrane Proteins

Study Officials

  • Assaf Stein, Md

    resident

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2011

First Posted

September 7, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 8, 2015

Record last verified: 2012-03

Locations

IL(1)