Cytokine Profiles and suPAR in Spondylodiscitis

NCT02554227 | Completed

• 1 other identifier: Uni-Köln_11_2014
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylodiscitis

Keywords

Spondylodiscitis; erosive osteochondrosis; infection; cytokine profiles; lumbar, thoracic spine; suPAR

Outcome Measures

Primary Outcomes (1)

• Number of patients with high cytokine and suPAR profiles as a measurement for the diagnosis of spondylodiscitis

  different cytokine and suPAR profiles between groups

  Change from Baseline in different Cytokine and suPAR profiles to 3 month after surgery

Secondary Outcomes (1)

• Number of patients with high cytokine and suPAR profiles as a measurement for the diagnosis of vertebral osteomyelitis

  Change from Baseline in different Cytokine and suPAR profiles to 3 month after surgery

Study Arms (1)

Spondylodiscitis

vertebral osteomyelitis, erosive osteochondrose

Other: Cytokine Profile and suPAR

Interventions

Cytokine Profile and suPAR OTHER

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.

Spondylodiscitis

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with spondylodiscitis, erosive osteochondrosis

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Studienzentrum Orthopädie & Unfallchirurgie

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Related Publications (1)

• Scharrenberg JS, Yagdiran A, Brinkmann J, Brune M, Siewe J, Jung N, Mahabir E. The diagnostic value of soluble urokinase-type plasminogen activator receptor (suPAR) for the discrimination of vertebral osteomyelitis and degenerative diseases of the spine. J Orthop Surg Res. 2019 Nov 14;14(1):367. doi: 10.1186/s13018-019-1420-6.

  PMID: 31727136 DERIVED

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)

MeSH Terms

Conditions

Discitis; Infections

Condition Hierarchy (Ancestors)

Spondylitis; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Study Officials

• Jan Siewe, Dr. med.

  University Hospital, Department of Orthopaedic Surgery and Traumatology,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

DE (1)