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sCD163 as a Potential Biomarker in Guillain- Barré Syndrome (GBS)

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ClinicalTrials.gov Identifier: NCT02582853
Recruitment Status : Unknown
Verified October 2015 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : October 21, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment
Guillain-Barre Syndrome Procedure: Lumbar puncture Procedure: Blood Sample

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Official Title: sCD163 as a Potential Biomarker in Guillain- Barré Syndrome
Study Start Date : September 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : January 2018


Group/Cohort Intervention/treatment
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

Procedure: Lumbar puncture
Lumbar puncture for spinal fluid
Other Name: Spinal tap

Procedure: Blood Sample
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.
Procedure: Lumbar puncture
Lumbar puncture for spinal fluid
Other Name: Spinal tap

Procedure: Blood Sample
Blood sample




Primary Outcome Measures :
  1. Concentration of sCD163 in patients with GBS [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Concentration of sCD163 in patients with GBS after treatment [ Time Frame: Week 4 ]

Biospecimen Retention:   Samples Without DNA
Spinal fluid and blood sample for identification of different factors


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of two groups:

  1. Patients diagnosed with GBS
  2. Symptomatic controls
Criteria

Inclusion Criteria:

  • Progressive muscle weakness with acute onset (< 2 weeks)
  • Areflexia

Exclusion Criteria:

  • Other cause of peripheral neuropathy
  • Malignant disease
  • Age < 18 years
  • Unable to give informed consent
  • Ongoing infection

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): NCT02582853


Contacts
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Contact: Malalai Musleh, Student +45 27134658 malalaimusleh@hotmail.com
Contact: Henning Andersen, Professor +45 78463281 hennande@rm.dk

Locations
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Denmark
The Department of Neurology, Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Malalai Musleh, Student    +45 27134658    malalaimusleh@hotmail.com   
Contact: Henning Andersen, Professor    +45 78463281    hennande@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Henning Andersen, Professor Department of Neurology

Publications:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02582853     History of Changes
Other Study ID Numbers: GBS CD163
1-10-72-256-15 ( Other Identifier: The National Committee on Health Research Ethics (Denmark) )
1-16-02-522-15 ( Other Identifier: The Danish Data Protection Agency )
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by University of Aarhus:
GBS
AIDP
Spinal fluid
sCD163

Additional relevant MeSH terms:
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Syndrome
Guillain-Barre Syndrome
Disease
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases