Syndecan 1 as Biomarker for Inflammation

NCT ID: NCT02333526

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-31

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subject with at least 18 years of age
* able to give informed consent
* healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis)

Exclusion Criteria

* not able to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helios Albert-Schweitzer-Klinik Northeim

OTHER

Sponsor Role lead

Responsible Party

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Tobias Meister

Priv.-Doz. Dr. med. Tobias Meister

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tobias Meister, PD Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Helios Albert-Schweitzer-Klinik Northeim

Locations

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University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

Site Status

Helios Albert-Schweitzer-Klinik Northeim

Northeim, Lower Saxony, Germany

Site Status

Countries

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Germany

Central Contacts

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Tobias Meister, PD Dr.med.

Role: CONTACT

+495551971244

Facility Contacts

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Steffen Kunsch, PDDr.med.

Role: primary

+39555139-0

Tobias Meister, PD Dr.med.

Role: primary

+495551971244

References

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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.

Reference Type DERIVED
PMID: 34286513 (View on PubMed)

Other Identifiers

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Syndecan-NOM

Identifier Type: -

Identifier Source: org_study_id

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