Cross-Sectional ALS Biofluid Biomarker (CABB) Study
Study Purpose:
The purpose of this trial is to extend and enlarge a biofluid repository of blood (including DNA), urine and CSF collected from people with ALS and controls, which will be shared with medical researchers to understand ALS and other diseases.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Primary Lateral Sclerosis (PLS), Hereditary Spastic Paraplegia (HSP), Healthy Volunteer, Healthy Volunteer with a Family History of ALS, Presymptomatic ALS Gene CarrierStudy Type:
Observational StudyStudy Category:
Biomarker/BiorepositoryStudy Status:
EnrollingPhase:
Not ApplicableStudy Chair(s)/Principal Investigator(s):
James D. Berry, MD, MPH (Massachusetts General Hospital)
Clinicaltrials.gov ID (11 digit #):
Neals Affiliated?
YesCoordinating Center Contact Information
Massachusetts General Hospital (NCRI)Armineuza Evora / .(JavaScript must be enabled to view this email address) / 617-724-5984
.(JavaScript must be enabled to view this email address) 165 Cambridge Street
Boston, Massachusetts 02114 United States
Full Study Summary:
The aims of the proposed study are to extend and enlarge a biofluid repository of blood - plasma, serum, deoxyribonucleic acid (DNA), optional urine and cerebrospinal fluid (CSF) collected from people with amyotrophic lateral sclerosis (ALS) and controls to support research and identify biomarkers of ALS and other diseases. Investigators at multiple centers will participate in this collaborative study. The eventual goal is to enroll a total of up to 1,000 study participants. Once specific ALS biomarkers have been discovered, these could be used to make earlier diagnosis, monitoring disease progression, designing new therapies, or testing drug efficacy in clinical trials. Discovery of disease-specific biomarkers will shed light on the pathophysiology of ALS and could aid in developing disease modifying treatments. Samples will be shared with medical researchers to advance understanding of ALS and other diseases. Sample sharing will be performed through the Northeast ALS Consortium (NEALS) Biorepository and its sample request review committee. DNA collected from this study will be isolated and may be used in genome-wide association studies, specific gene identification, whole genome sequencing, or other targeted or untargeted gene studies.
Study Sponsor:
ALS Association (ALSA) and ALS Finding a CureParticipant Duration:
1 required in-person visit for all subjects; 2 more additional optional visits at 6 months and 12 months (can be done via telephone) for ALS/MND/Presymptomatic subjects; Subjects may be contacted periodically thereafter for follow-up.