sCD163 as a Potential Biomarker in Guillain- Barré Syndrome
GBS
3 other identifiers
observational
60
1 country
1
Brief Summary
Guillain- Barré syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy (AIDP) that often is triggered by an infection. GBS is characterized by progressing weakness and numbness and loss of tendon of reflexes. It can also include tingling sensation in the legs and arms. These symptoms occur due to an autoimmune attack on the myelin resulting in demyelination. The diagnosis is given by electrophysiological examination and clinical presentation. GBS is treated with intravenous immunoglobulin (IVIG) and plasma exchange (PE). Both treatments are equally effective. Most patients recover completely, while others must ease symptoms and reduce the duration of illness by several treatments. The purpose of this study is to define if patients with GBS have higher concentrations of sCD163 in their cerebrospinal fluid and serum compared with symptomatic control subjects. Furthermore it is to define if the concentrations of sCD163 reduces after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedOctober 22, 2015
October 1, 2015
1.2 years
October 19, 2015
October 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration of sCD163 in patients with GBS
Day 1
Secondary Outcomes (1)
Concentration of sCD163 in patients with GBS after treatment
Week 4
Study Arms (2)
Patients diagnosed with GBS
Patients will undergo a lumbar puncture as a part of the diagnostic procedure as soon as they are suspected to be suffering from GBS on clinical grounds with blood test. The procedure and a blood test will be repeated after 6 months. Lumbar puncture Blood sample
Symptomatic controls
Controls include patients with unspecified neurological symptoms or diseases who will undergo a lumbar puncture at the Department of Neurology at Aarhus University Hospital as part of their diagnostic work up irrespective of this study. We expect to include 40 symptomatic controls.
Interventions
Lumbar puncture for spinal fluid
Eligibility Criteria
The study population will consist of two groups: 1. Patients diagnosed with GBS 2. Symptomatic controls
You may qualify if:
- Progressive muscle weakness with acute onset (\< 2 weeks)
- Areflexia
You may not qualify if:
- Other cause of peripheral neuropathy
- Malignant disease
- Age \< 18 years
- Unable to give informed consent
- Ongoing infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Department of Neurology, Aarhus University Hospital
Aarhus C, 8000, Denmark
Related Publications (7)
Haunsø, Stig m.fl.: Medicinsk Kompendium: 18. Udgave, Nyt Nordisk forlag, 2013
BACKGROUNDBourque PR, Chardon JW, Massie R. Autoimmune peripheral neuropathies. Clin Chim Acta. 2015 Sep 20;449:37-42. doi: 10.1016/j.cca.2015.02.039. Epub 2015 Mar 4.
PMID: 25748038BACKGROUNDFuglsang-Frederiksen A, Pugdahl K. Current status on electrodiagnostic standards and guidelines in neuromuscular disorders. Clin Neurophysiol. 2011 Mar;122(3):440-455. doi: 10.1016/j.clinph.2010.06.025. Epub 2010 Jul 31.
PMID: 20673740BACKGROUNDMoller HJ. Soluble CD163. Scand J Clin Lab Invest. 2012 Feb;72(1):1-13. doi: 10.3109/00365513.2011.626868. Epub 2011 Nov 7.
PMID: 22060747BACKGROUNDEtzerodt A, Moestrup SK. CD163 and inflammation: biological, diagnostic, and therapeutic aspects. Antioxid Redox Signal. 2013 Jun 10;18(17):2352-63. doi: 10.1089/ars.2012.4834. Epub 2012 Oct 19.
PMID: 22900885BACKGROUNDKjaergaard AG, Rodgaard-Hansen S, Dige A, Krog J, Moller HJ, Tonnesen E. Monocyte expression and soluble levels of the haemoglobin receptor (CD163/sCD163) and the mannose receptor (MR/sMR) in septic and critically ill non-septic ICU patients. PLoS One. 2014 Mar 17;9(3):e92331. doi: 10.1371/journal.pone.0092331. eCollection 2014.
PMID: 24637679BACKGROUNDMerkies IS, Schmitz PI, van der Meche FG, Samijn JP, van Doorn PA; Inflammatory Neuropathy Cause and Treatment (INCAT) group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2002 May;72(5):596-601. doi: 10.1136/jnnp.72.5.596.
PMID: 11971045BACKGROUND
Biospecimen
Spinal fluid and blood sample for identification of different factors
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henning Andersen, Professor
Department of Neurology
Central Study Contacts
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 21, 2015
Study Start
September 1, 2015
Primary Completion
November 1, 2016
Study Completion
January 1, 2018
Last Updated
October 22, 2015
Record last verified: 2015-10