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.
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.
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.
- Conditions
- Inflammatory Bowel Diseases
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood sample - venous blood 10 ml. | |
| No disease | Healthy 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.
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)
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
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
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
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.
- First posted7 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Assaf Stein, Md, Principal investigator, resident
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 21310817Bartlett 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 17978567Bode 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 18064305Carey DJ. Syndecans: multifunctional cell-surface co-receptors. Biochem J. 1997 Oct 1;327 ( Pt 1)(Pt 1):1-16. doi: 10.1042/bj3270001.
PubMed 9355727Seidel 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 10627439Principi 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 16873088Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.
PubMed 12665470Gaffney 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 1670865Day 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 12824007Day 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndecan-1 as a Surrogate Marker for Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01430039
- Acronym / sponsor ID
- syndecan1 / 03.09.11.01
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn's disease, ulcerative colitis, Syndecan-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's, ulcerative colitis | – | Procedure: Blood sample - venous blood 10 ml.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. |
| No disease | – | Procedure: blood sampleHealthy subjects with no known inflammatory disease. For basal serum levels of syndecan 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal population, having no known inflammatory disease
Key inclusion criteria (3 listed)
- informed consent
- no other concurrent inflammatory disease
- formal diagnosis of inflammatory bowel disease i.e Crohn's disease, Ulcerative colitis
Key exclusion criteria (2 listed)
- pregnancy
- fever at time of sample taking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleAlso: Syndecan-1Blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1 | Procedure or surgery | No disease |
| Blood sample - venous blood 10 ml.Also: Syndecan-1venous blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1 | Procedure or surgery | Crohn's, ulcerative colitis |
Primary outcome
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
4 secondary outcomes
Serum syndecan-1 levels and disease severity Crohn's
Time frame: one year
Serum syndecan-1 levels and disease severity ulcerative colitis
Time frame: one year
Serum syndecan-1 levels and C reactive protein(CRP) Crohn's
Time frame: one year
Serum syndecan-1 levels and C reactive protein(CRP) ulcerative colitis
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Background: PubMed 21310817Yablecovitch 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.
- Background: PubMed 17978567Bartlett 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.
- Background: PubMed 18064305Bode 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.
- Background: PubMed 9355727Carey DJ. Syndecans: multifunctional cell-surface co-receptors. Biochem J. 1997 Oct 1;327 ( Pt 1)(Pt 1):1-16. doi: 10.1042/bj3270001.
- Background: PubMed 10627439Seidel 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.
- Background: PubMed 16873088Principi 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.
- Background: PubMed 12665470Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.
- Background: PubMed 1670865Gaffney 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.
- Background: PubMed 12824007Day 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.
- Background: PubMed 10630505Day 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assaf Stein, Md principal investigator
resident
1 site in 1 country: see every site and its status.
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.