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
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|
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|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|
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.
- 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
- 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
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
|Studienzentrum Orthopädie & Unfallchirurgie|
|Cologne, NRW, Germany, 50931|
|Principal Investigator:||Jan Siewe, Dr. med.||University Hospital, Department of Orthopaedic Surgery and Traumatology,|