Amyotrophic lateral sclerosis and the innate immune system: protocol for establishing a biobank and statistical analysis plan

Abstract

IntroductionAmyotrophic 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 analysisWe 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 disseminationThe 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 numberNCT02869048

Prediction of survival in amyotrophic lateral sclerosis: a nationwide, Danish cohort study

“…Ethics approval and consent to participate This cohort study was retrospectively carried out in a prospectively included cohort of ALS patients who participated in an explorative study with a focus on the innate immune system. The protocol for the prospective study was registered on Clinicaltrials.gov (NCT02869048) and has been previously published [22]. 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) approved the study and written informed consent was obtained from all the participants.…”

Complement Profiles in Patients with Amyotrophic Lateral Sclerosis: A Prospective Observational Cohort Study

“…As previously described, 28 we included adults (> 18 years) into the following groups: ALS cohort: Patients who were referred to or followed at five large Danish motor-neuron disease outpatient clinics were recruited if they fulfilled the El Escorial Revised criteria 29 for probable or definite ALS. Neurologically healthy controls (NHCs): Healthy patients (American Society of Anesthesiologists score, 1–2) scheduled for planned orthopaedic surgery in spinal anaesthesia at a large elective surgical centre were included.…”

“…Samples of EDTA plasma, serum, and CSF were kept at −20 °C during transportation and stored at −80 °C until analysis. 28

Figure 1 Inclusion of patients.

…”

“…As previously described, 28 we included adults (> 18 years) into the following groups: For both control groups (NHCs and NCs), patients with a history or symptoms of motor neuron disease, acute or chronic inflammatory disease, or autoimmune disease were excluded.…”

“…Samples of EDTA plasma, serum, and CSF were kept at −20 °C during transportation and stored at −80 °C until analysis. 28 The level of the complement lectin pathway components ficolin-1, ficolin-2, ficolin-3, collectin-11, mannose-binding lectin (MBL), MBL/ficolin/collectin-associated serine protease 3 (MASP-3), MBL/ficolin/collectin associated protein submit your manuscript | www.dovepress.com…”