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Cytokine Profiles and suPAR in Spondylodiscitis

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ClinicalTrials.gov Identifier: NCT02554227
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ayla Yagdiran, University of Cologne

Brief Summary:

Spondylodiscitis is an infectious disease of the intervertebral discs and adjacent vertebral bodies, which often has a protracted progression. Diagnosis is frequently delayed because of the unspecific pathology and a lack of specific infection markers. However, an early diagnosis is fundamental to prevent long periods with symptoms including extensive back pain and progressive and destructive changes of the spine.

Cytokines can be helpful to extend the knowledge about diverse biological processes. Furthermore, they are a promising category of biomarkers that are already present in the early phases of developing diseases. Currently, little is known about the participation of cytokines in Spondylodiscitis. The aim of this study is to establish a non-invasive method to improve the diagnosis of spondylodiscitis. Therefore, blood and tissue samples will be analyzed at different time points for the concentration of specific cytokines to select potential marker cytokines via a Multiplex Assay and suPAR (soluble urokinase-type plasminogen activator receptor) via ELISA. After successful identification of the biomarkers cytokines and suPAR, verification of the results will be done by expression analysis of cytokine-producing cells.

The potential of such a diagnostic method lies in reducing medical costs and preventing extensive pain and structural changes of the spine.

Experimental research will be performed with the approval of the ethic committee of the medical faculty of the University of Cologne.


Condition or disease Intervention/treatment
Spondylodiscitis Other: Cytokine Profile and suPAR

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Verification and Progress of Cytokine Profiles and suPAR for the Discrimination of Infectious and Non-infectious, Degenerative Diseases of the Spine
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : August 2017

Group/Cohort Intervention/treatment
Spondylodiscitis
vertebral osteomyelitis, erosive osteochondrose
Other: Cytokine Profile and suPAR
Routine blood collection will be carried out directly before surgery and also during the stationary hospitalization on day 4 and day 10. Additional blood collection will be done after 6 weeks and 3 months during the follow-up.




Primary Outcome Measures :
  1. Number of patients with high cytokine and suPAR profiles as a measurement for the diagnosis of spondylodiscitis [ Time Frame: Change from Baseline in different Cytokine and suPAR profiles to 3 month after surgery ]
    different cytokine and suPAR profiles between groups


Secondary Outcome Measures :
  1. Number of patients with high cytokine and suPAR profiles as a measurement for the diagnosis of vertebral osteomyelitis [ Time Frame: Change from Baseline in different Cytokine and suPAR profiles to 3 month after surgery ]
    cytokines and suPAR in tissues/cells


Biospecimen Retention:   Samples With DNA
Bio-Plex Pro Human Cytokine Group I 27-plex Assay (IL-1β, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, FGF basic, Eotaxin, G-CSF, GM-CSF, IFN-γ, IP-10, MCP-1, MIP-1α, MIP-1β, PDGF-BB, RANTES, TNF-α, VEGF), suPAR (soluble urokinase-type plasminogen activator receptor)


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with spondylodiscitis, erosive osteochondrosis
Criteria

Inclusion Criteria:

  • Existence of an informed consent
  • Legal competence of the patient
  • Lumbar and thoracic spine pathology with an indication of spondylodiscitis or rather erosive osteochondrosis
  • Surgical stabilization of the affected lumbar and thoracic vertebral bodies and a removal of the affected intervertebral discs

Exclusion Criteria:

• Patients with autoimmune diseases, chronic infections (HIV, hepatitis B and C), acute infections of other parts besides the spine and active cancer diseases


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554227


Locations
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Germany
Studienzentrum Orthopädie & Unfallchirurgie
Cologne, NRW, Germany, 50931
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Jan Siewe, Dr. med. University Hospital, Department of Orthopaedic Surgery and Traumatology,
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ayla Yagdiran, Dr.med., University of Cologne
ClinicalTrials.gov Identifier: NCT02554227    
Other Study ID Numbers: Uni-Köln_11_2014
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Ayla Yagdiran, University of Cologne:
Spondylodiscitis
erosive osteochondrosis
infection
cytokine profiles
lumbar, thoracic spine
suPAR
Additional relevant MeSH terms:
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Discitis
Spondylitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases