Syndecan 1 as Biomarker for Inflammation
Soluble Syndecan 1 as Biomarker for Acute and Chronic Bowel Inflammation
1 other identifier
observational
44
1 country
2
Brief Summary
The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from venous blood of patients with infectious intestinal diseases such as Clostridium difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients with active inflammation and with disease in remission. Secondary objectives were the assessment of correlation of the above-mentioned factors with the CRP value. Subjects will be volunteers. Blood will be taken as part of the routine clinical work-up after the written agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay. In addition, the subjects are asked to answer a short questionnaire. The study is designed as a prospective, comparative cohort study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2015
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFebruary 12, 2019
February 1, 2019
Same day
January 6, 2015
February 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Soluble serum Syndecan-1 in ng/ml
6 months
Secondary Outcomes (6)
Underlying disease
6 months
Patient age
6 Months
Disease activity in Inflammatory bowel disease
6 Months
Calprotectin in stool
6 Months
Leucocyte blood count
6 Months
- +1 more secondary outcomes
Eligibility Criteria
Subjects with inflammatoy bowel disease, infectious colitis and healthy volunteers
You may qualify if:
- Subject with at least 18 years of age
- able to give informed consent
- healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis)
You may not qualify if:
- not able to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075, Germany
Helios Albert-Schweitzer-Klinik Northeim
Northeim, Lower Saxony, 37154, Germany
Related Publications (1)
Floer M, Clausen M, Meister T, Vollenberg R, Bettenworth D, Tepasse PR. Soluble syndecan-1 as marker of intestinal inflammation: A preliminary study and evaluation of a new panel of biomarkers for non-invasive prediction of active ulcerative colitis. Adv Clin Exp Med. 2021 Jul;30(7):655-660. doi: 10.17219/acem/139040.
PMID: 34286513DERIVED
Biospecimen
blood serum for soluble Syndecan 1 and CRP Leucocyte cound Blood panel Stool analysis for calprotectin
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Meister, PD Dr.med.
Helios Albert-Schweitzer-Klinik Northeim
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priv.-Doz. Dr. med. Tobias Meister
Study Record Dates
First Submitted
January 6, 2015
First Posted
January 7, 2015
Study Start
December 1, 2019
Primary Completion
December 1, 2019
Study Completion
July 1, 2020
Last Updated
February 12, 2019
Record last verified: 2019-02