ColitisNCT02333526
Syndecan 1 as Biomarker for Inflammation
An observational study of Colitis, run by Helios Albert-Schweitzer-Klinik Northeim at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colitis
- How many people
- 44 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2019to Jul 2020
- How long will I take part?
- 2 Days
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with inflammatoy bowel disease, infectious colitis and healthy volunteers
Who may be able to join
- Subject with at least 18 years of age
- able to give informed consent
- healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis)
Who cannot join
- not able to give informed consent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
Steffen Kunsch, PDDr.med., +39555139-0, steffen.kunsch@med.uni-goettingen.de
Volker Ellenrieder, Prof.
Helios Albert-Schweitzer-Klinik Northeim
Northeim, Lower Saxony, 37154
Tobias Meister, PD Dr.med., +495551971244, tobiasmeister@helios-kliniken.de
Martin Floer, Dr.med.
About this study
Official title: Soluble Syndecan 1 as Biomarker for Acute and Chronic Bowel Inflammation
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.
- Conditions
- Colitis
- Keywords
- ulcerative colitis, Clostidium difficile-associated colitis, Syndecan-1, biomarker
- Medical subject headings
- Colitis, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Soluble serum Syndecan-1 in ng/ml
Measured: 6 months
Secondary outcomes (6)
Underlying disease
Measured: 6 months
Patient age
Measured: 6 Months
Disease activity in Inflammatory bowel disease
Measured: 6 Months
Calprotectin in stool
Measured: 6 Months
Leucocyte blood count
Measured: 6 Months
CRP in serum
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startDec 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColitisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Helios Albert-Schweitzer-Klinik Northeim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Meister, Helios Albert-Schweitzer-Klinik Northeim
- Investigators
- Tobias Meister, PD Dr.med., Principal investigator, Helios Albert-Schweitzer-Klinik Northeim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333526
- Sponsor's protocol ID
- Syndecan-NOM
- Status last verified
- Feb 2019
- First submitted
- 6 Jan 2015
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34286513
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Syndecan 1 as Biomarker for Acute and Chronic Bowel Inflammation
- ClinicalTrials.gov ID
- NCT02333526
- Acronym / sponsor ID
- Syndecan-NOM
- Conditions
- Colitis
- Keywords
- ulcerative colitis, Clostidium difficile-associated colitis, Syndecan-1, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Helios Albert-Schweitzer-Klinik NortheimUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 7 Jan 2015 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with inflammatoy bowel disease, infectious colitis and healthy volunteers
Key inclusion criteria (3 listed)
- Subject with at least 18 years of age
- able to give informed consent
- healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis)
Key exclusion criteria (1 listed)
- not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Soluble serum Syndecan-1 in ng/ml
Time frame: 6 months
6 secondary outcomes
Underlying disease
Time frame: 6 months
Patient age
Time frame: 6 Months
Disease activity in Inflammatory bowel disease
Time frame: 6 Months
Calprotectin in stool
Time frame: 6 Months
Leucocyte blood count
Time frame: 6 Months
CRP in serum
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Derived from this study: PubMed 34286513Floer 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.
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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.
Tobias Meister, PD Dr.med. principal investigator
Helios Albert-Schweitzer-Klinik Northeim
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis, run by Helios Albert-Schweitzer-Klinik Northeim at 2 sites in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Meister, PD Dr.med. (+495551971244, tobias.meister@helios-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soluble serum Syndecan-1 in ng/ml (time frame: 6 months). 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 NCT02333526, which also lists 1 linked publication.
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 12 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.