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Inflammatory Bowel Diseasessyndecan1NCT01430039

Syndecan-1 a Surrogate Marker for IBD

An observational study of Inflammatory Bowel Diseases, run by Meir Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
blood sample and Blood sample - venous blood 10 ml.
Type of treatment
Surgery or procedure
How many people
42 participants
Where
1 siteIsrael
Study dates
Oct 2011to Apr 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Normal population, having no known inflammatory disease

Who may be able to join

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

Who cannot join

  • pregnancy
  • fever at time of sample taking

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Meir Medical Center

    Kfar Saba

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Being tested
blood sample, Blood sample - venous blood 10 ml.
Keywords
Crohn's disease, ulcerative colitis, Syndecan-1
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood sampleProcedure or surgery

    Also called Syndecan-1

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

  • Blood sample - venous blood 10 ml.Procedure or surgery

    Also called Syndecan-1

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

Study groups in NCT01430039
Study groupRoleWhat they receive
Crohn's, ulcerative colitisPatients 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.
Receives: Procedure: Blood sample - venous blood 10 ml.
No diseaseHealthy subjects with no known inflammatory disease. For basal serum levels of syndecan 1
Receives: Procedure: blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: one year

Secondary outcomes (4)

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

    Relationship between clinical data CDAI in crohn's patients and serum syndecan-1 levels

    Measured: one year

  2. Serum syndecan-1 levels and disease severity ulcerative colitis

    Relationship between clinical data UCAI ulcerative colitis patients and serum syndecan-1 levels

    Measured: one year

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

    Relationship between lab data CRP levels in crohn's patients and serum syndecan-1 levels

    Measured: one year

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

    Relationship between serum CRP levels and serum syndecan-1 levels in patients with ulcerative colitis

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01430039
Sponsor's protocol ID
03.09.11.01
Other IDs
31.08.11
Acronym
syndecan1
Status last verified
Mar 2012
First submitted
28 Aug 2011
Last updated
8 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21310817

  • 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.

    PubMed 17978567

  • 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.

    PubMed 18064305

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

    PubMed 9355727

  • 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.

    PubMed 10627439

  • 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.

    PubMed 16873088

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

    PubMed 12665470

  • 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.

    PubMed 1670865

  • 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.

    PubMed 12824007

  • 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.

    PubMed 10630505

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases, run by Meir Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elevated serum syndecan-1 levels as a bio marker for IBD (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430039, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.

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