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NCT05137665Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
16 Nov 2021
Start date
1 Jun 2021
Primary completion date
31 Dec 2031
Lead sponsor
Target ALS Foundation, Inc.
NCT number
NCT05137665

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 1 Jun 2021 to the primary completion date, 31 Dec 2031
  • 12 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • ALS Participants:
  • 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.
  • Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.
    • Healthy Control Participants:
  • Age 18 or older.
  • No history of neurological disease, in the opinion of the Principal Investigator.
  • No known ALS- associated genetic mutations at the time of consent.
  • Ability to provide informed consent and understand the purpose and risks of the study.
  • Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Roosevelt
Coordinator of this site? Confirm its status
BogotáColombiaRecruiting
CHALS-CCT UPR MScience
Coordinator of this site? Confirm its status
San JuanPuerto RicoRecruiting
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Georgetown University
Coordinator of this site? Confirm its status
GeorgetownUnited StatesRecruiting
Baylor College of Medicine
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Columbia University
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Barrow Neurological Institute
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
University of California San Diego
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting
University of Washington
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Washington University
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.