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Clinical Research in ALS Study (CRiALS)

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ClinicalTrials.gov Identifier: NCT00136500
Recruitment Status : Recruiting
First Posted : August 29, 2005
Last Update Posted : April 13, 2022
Sponsor:
Collaborators:
ALS Association
ALS Recovery Fund
Information provided by (Responsible Party):
Michael Benatar, University of Miami

Study Description
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Brief Summary:
CRiALS is an umbrella protocol through which people are recruited to participate in a range of research studies being conducted by the ALS Research Collaboration (ARC).

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:
Research goals include elucidation of the complex relationship between ALS and related neurodegenerative disorders, development of both wet and dry biomarkers of disease, and delineation of the full course of the natural history of disease from the early pre-symptomatic stages through established and even late-stage disease. These goals are accomplished through the recruitment and evaluation of patients with ALS and related diseases, family members (including people at genetic risk for ALS, but who are not yet affected), and healthy controls.
Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Research in Amyotrophic Lateral Sclerosis
Study Start Date : February 2005
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Individuals affected with ALS
This population be sporadic or familial ALS.
Unaffected individuals from families in which the genetic cause of ALS is known
This population includes pre-symptomatic individuals at genetic risk for ALS or a related neurodegenerative disorder (i.e., FTD).
Individuals affected with an ALS-related neurodegenerative disease
This would include FTD, MSP, IBMPFD, etc.
Healthy controls


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment [ Time Frame: Annually ]
    Since this is an umbrella/gateway protocol through which individuals are recruited to participate in a range of studies, outcome is assessed in terms of recruitment.


Biospecimen Retention:   Samples With DNA
DNA, blood, urine, CSF, skin biopsies

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The CRiALS research program aims to recruit three types of participants:

  • Individuals affected with ALS or a related neurodegenerative disease
  • Unaffected individuals from pedigrees in which the genetic cause of ALS is known
  • Healthy controls
Criteria

Inclusion Criteria:

  1. At least 18 years of age.

  2. Member of at least one of the following categories:

    1. Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
    2. Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
    3. Healthy controls
  3. Able and willing to comply with relevant procedures.

Exclusion Criteria:

1. Subject has a condition or is in a 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 -- including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136500


Contacts
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Contact: Anne-Laure Grignon, MD 888-413-9315 fals@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Anne-Laure Grignon, MD    888-413-9315    fals@med.miami.edu   
Sponsors and Collaborators
University of Miami
ALS Association
ALS Recovery Fund
Investigators
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Principal Investigator: Michael Benatar, MD, PhD. University of Miami
More Information
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Additional Information:

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Responsible Party: Michael Benatar, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00136500    
Other Study ID Numbers: 20101021
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Benatar, University of Miami:
genetics
biomarkers
pre-symptomatic
natural history
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases