TRIAL READY (Clinical Trial Readiness)

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    610
  • sponsor
    University of Miami
Updated on 30 October 2021
Accepts healthy volunteers

Summary

This study, being conducted under the auspice of the CReATe Consortium, will enroll patients with ALS and related disorders as well as healthy controls, with the goal of facilitating clinical validation of leading biological-fluid based biomarker candidates that may aid therapy development for patients with ALS and related disorders.

Description

This multi-center study aims to clinically validate leading biological-fluid-based biomarker candidates as potential prognostic and pharmacodynamic biomarkers that have the potential to facilitate therapy development for patients with ALS and related disorders. Biomarker candidates that will be considered include: urinary p75 neurotrophin receptor extracellular domain (p75ECD), blood and cerebrospinal fluid (CSF) phosphorylated neurofilament heavy (pNfH), blood and CSF neurofilament light (NfL) and, in the population with a C9orf72 hexanucleotide repeat expansion, peripheral blood mononuclear cell (PBMC) and CSF levels of the dipeptide repeat protein poly(GP). In pursuit of these goals, the CReATe Consortium is already collecting longitudinal biological samples from patients with ALS and related disorders through the ongoing Phenotype-Genotype-Biomarker (PGB) study. TRIAL READY aims to identify additional patients with the C9orf72 hexanucleotide repeat expansion mutation (HREM), the most common genetic cause of ALS, who may be further followed through the PGB study. This study will also enroll and longitudinally evaluate a cohort of age- and gender-match healthy controls.

Details
Condition Frontotemporal Dementia, Spinal Muscular Atrophy, Myelopathy, Pick's Disease, Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, ALS-Frontotemporal Dementia, ALS-Frontotemporal Dementia, ALS-Frontotemporal Dementia, ALS-Frontotemporal Dementia, primary lateral sclerosis, lateral sclerosis, progressive muscular atrophy, dementia, frontotemporal, lou gehrig's disease, ALS-Frontotemporal Dementia, ALS-Frontotemporal Dementia, ALS-Frontotemporal Dementia, ALS-Frontotemporal Dementia, ALS-Frontotemporal Dementia
Clinical Study IdentifierNCT03912987
SponsorUniversity of Miami
Last Modified on30 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Member of at least one of the following categories
Individuals with a clinical diagnosis of ALS or a related disorder, including FTD, ALS-FTD, PLS, and PMA
Individuals never diagnosed with and not at particular risk of developing ALS or a related disorder
Able and willing to comply with relevant procedures

Exclusion Criteria

A condition or situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol. This includes (but is not limited to) neurological, psychological and/or medical conditions
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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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