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DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01699451
Collaborator
(none)
33
Enrollment
1
Location
27
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is intended to obtain clinical information and establish a repository of DNA, RNA, peripheral blood monocyte, lymphocyte and skin tissue samples from people with ALS and related neurodegenerative motor neuron diseases, people with a family history of these conditions, and healthy people with no family history of these disorders. The samples will be used in future research to learn about how these disorders affect people, what causes these conditions, and how the investigators can tell when someone has this kind of disease. Future research may also include the generation of stem cells from stored blood cell and skin cell samples. Participants will not be paid for taking part in this study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    33 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida
    Study Start Date :
    Sep 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Repository sample collection [once]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • ALS Patient

    1. Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified EL Escorial criteria, suspected ALS according to original El Escorial criteria, or diagnosis of a neurodegenerative disorder with evidence of ALS plus extramotor features

    2. or = 18 years of age and willing to provide consent, or assent, if unable to consent

    • Subject with family history of ALS or other relevant neurodegenerative disease

    1. No personal history of ALS, ALS-FTD or other motor neuron disease

    2. Family history of ALS, ALS-FTD in a first, second or third degree blood relative

    3. or = 18 years of age and willing to provide consent

    • Control

    1. No personal or family history (first or second degree blood relative) of ALS, dementia, Parkinson disease or other relevant neurodegenerative disorder

    2. or = 18 years of age and willing to provide consent

    Exclusion Criteria:
    • ALS Subject and subject with family history of ALS/ALS-FTD or other neurodegenerative motor neuron disorder but no personal history of such conditions

    1. History of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be contributed to by an acquired condition

    2. Limited mental capacity rendering the subject unable to comply with skin punch biopsy or standard phlebotomy procedures

    3. For collection of skin punch biopsy, an increased risk of bleeding complications or allergy to local anesthetic administered at the time of skin biopsy

    • Healthy Control Subject

    1. Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.)

    2. Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures

    3. For collection of skin punch biopsy, an increased risk of bleeding complications or allergy to local anesthetic administered at the time of skin biopsy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Bjorn Oskarsson, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bjorn E. Oskarsson, PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01699451
    Other Study ID Numbers:
    • 12-004718
    First Posted:
    Oct 3, 2012
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Neurodegenerative Diseases

    Study Results

    No Results Posted as of Feb 15, 2022