Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTarget ALS Foundation, Inc.
About this trial
The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 or older.
A diagnosis of ALS in accordance with Gold Coast criteria.
Full Vital Capacity (FVC) of ≥30% or at the discretion of the Principal Investigator for the participant's predicted value for gender, height, and age at the time of screening.
Ability to provide informed consent and understand the purpose and risks of the study.
Disqualifiers
None
Trial population
A biorepository of longitudinal blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community will be made from ALS and healthy control participants. This is a large multi-center study, including several international sites with the goal of developing a robust sample set from genetic and racially diverse populations. To enable well-powered biomarker research, the enrollment goal is at least 800 ALS patients and 200 healthy participants in five years.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Amyotrophic Lateral Sclerosis ALS
Group B: Healthy
Trial outcomes
Primary outcomes
1
Biofluid Biorepository
This project will create a biorepository of longitudinal biofluid samples, linked to clinical measures, and at home measures
Time frame
+ 3.5 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov