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The Capital Region of Denmark - a part of Copenhagen University Hospital
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Amyotrophic lateral sclerosis and the innate immune system: protocol for establishing a biobank and statistical analysis plan

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INTRODUCTION: Amyotrophic lateral sclerosis (ALS) is a devastating, progressive disease that causes degeneration of the motor neurons leading to paresis of the bulbar and the skeletal musculature. The pathogenesis of ALS remains unknown. We will test the hypothesis that the complement system is involved in the pathophysiology of ALS. This protocol article describes our efforts to establish a national Danish ALS biobank. The primary aim is to obtain biological material from patients with ALS for the current study as well as for future studies.

METHODS AND ANALYSIS: We intend to establish an observational ALS biobank; some of the material from this biobank will be used for a prospective, observational case-control study. The participants are patients with ALS, neurologically healthy controls and non-ALS neurological controls. Each participant consents to be interviewed and to donate blood and cerebrospinal fluid to the biobank. Analysis of the complement system will be carried out on the three groups of patients and compared.

ETHICS AND DISSEMINATION: The project has been approved by the Committees on Health Research Ethics in the Capital Region of Denmark (Approval number H-16017145) and the Danish Data Protection Agency (file number 2012-58-0004). All results will be published in peer-reviewed, medical journals and presented at scientific conferences.

TRIAL REGISTRATION NUMBER: NCT02869048.

Original languageEnglish
Article numberE037753
JournalBMJ Open
Volume10
Issue number8
Pages (from-to)e037753
Number of pages8
ISSN2044-6055
DOIs
Publication statusPublished - 5 Aug 2020

    Research areas

  • adult neurology, immunology, motor neurone disease, neuropathology

ID: 61252249