RecruitingNCT05137665

Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures

Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At - Home Measures


Sponsor

Target ALS Foundation, Inc.

Enrollment

1,000 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks people with ALS (amyotrophic lateral sclerosis, also called Lou Gehrig's disease) over time by collecting blood, spinal fluid, and other biological samples alongside physical and at-home measurements, to find better markers for tracking disease progression. **You may be eligible if...** - You are 18 or older - You have been diagnosed with ALS - Your lung function (FVC) is at least 30% of expected - OR you are a healthy volunteer aged 18+ with no neurological disease **You may NOT be eligible if...** - You cannot provide informed consent - Your lung function is below 30% (unless the investigator makes an exception) - You have a significant neurological disease (for healthy controls) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(12)

Barrow Neurological Institute

Phoenix, Arizona, United States

University of California San Diego

San Diego, California, United States

Georgetown University

Georgetown, District of Columbia, United States

Mayo Clinic

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Columbia University

New York, New York, United States

Baylor College of Medicine

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Instituto Roosevelt

Bogotá, Colombia

CHALS-CCT UPR MScience

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT05137665


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