<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01699451</url>
  </required_header>
  <id_info>
    <org_study_id>12-004718</org_study_id>
    <nct_id>NCT01699451</nct_id>
  </id_info>
  <brief_title>DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida</brief_title>
  <official_title>DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to obtain clinical information and establish a repository of DNA, RNA,&#xD;
      peripheral blood monocyte, lymphocyte and skin tissue samples from people with ALS and&#xD;
      related neurodegenerative motor neuron diseases, people with a family history of these&#xD;
      conditions, and healthy people with no family history of these disorders. The samples will be&#xD;
      used in future research to learn about how these disorders affect people, what causes these&#xD;
      conditions, and how the investigators can tell when someone has this kind of disease. Future&#xD;
      research may also include the generation of stem cells from stored blood cell and skin cell&#xD;
      samples. Participants will not be paid for taking part in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Repository sample collection</measure>
    <time_frame>once</time_frame>
  </primary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>Amyotrophic Lateral Sclerosis (ALS)</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      This study will establish a repository of stored DNA, RNA, monocyte, lymphocyte and skin&#xD;
      fibroblast samples from people with ALS and ALS-FTD, subjects with a family history of ALS&#xD;
      who do not have ALS or ALS-FTD, and subjects with no personal history of ALS or dementia, to&#xD;
      support future translational and basic research studies on ALS and related neurodegenerative&#xD;
      disorders.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible patients will be female or male, &gt; or = 18 years of age. ALS and control subjects&#xD;
        will meet eligibility criteria. Control subjects will be similar in age to ALS patients. No&#xD;
        special classes of subjects are specifically sought or excluded from the protocol.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ALS Patient&#xD;
&#xD;
               1. Clinical diagnosis of possible, laboratory-supported probable, probable or&#xD;
                  definite ALS according to modified EL Escorial criteria, suspected ALS according&#xD;
                  to original El Escorial criteria, or diagnosis of a neurodegenerative disorder&#xD;
                  with evidence of ALS plus extramotor features&#xD;
&#xD;
               2. &gt; or = 18 years of age and willing to provide consent, or assent, if unable to&#xD;
                  consent&#xD;
&#xD;
          -  Subject with family history of ALS or other relevant neurodegenerative disease&#xD;
&#xD;
               1. No personal history of ALS, ALS-FTD or other motor neuron disease&#xD;
&#xD;
               2. Family history of ALS, ALS-FTD in a first, second or third degree blood relative&#xD;
&#xD;
               3. &gt; or = 18 years of age and willing to provide consent&#xD;
&#xD;
          -  Control&#xD;
&#xD;
               1. No personal or family history (first or second degree blood relative) of ALS,&#xD;
                  dementia, Parkinson disease or other relevant neurodegenerative disorder&#xD;
&#xD;
               2. &gt; or = 18 years of age and willing to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ALS Subject and subject with family history of ALS/ALS-FTD or other neurodegenerative&#xD;
             motor neuron disorder but no personal history of such conditions&#xD;
&#xD;
               1. History of medical disorder that leaves in question whether neurological signs&#xD;
                  and symptoms potentially related to a neurodegenerative disease may be&#xD;
                  contributed to by an acquired condition&#xD;
&#xD;
               2. Limited mental capacity rendering the subject unable to comply with skin punch&#xD;
                  biopsy or standard phlebotomy procedures&#xD;
&#xD;
               3. For collection of skin punch biopsy, an increased risk of bleeding complications&#xD;
                  or allergy to local anesthetic administered at the time of skin biopsy&#xD;
&#xD;
          -  Healthy Control Subject&#xD;
&#xD;
               1. Personal or family history of dementia or other neurodegenerative disease&#xD;
                  (Parkinson disease, Alzheimer disease, etc.)&#xD;
&#xD;
               2. Limited mental capacity rendering the subject unable to provide written informed&#xD;
                  consent or comply with standard phlebotomy procedures&#xD;
&#xD;
               3. For collection of skin punch biopsy, an increased risk of bleeding complications&#xD;
                  or allergy to local anesthetic administered at the time of skin biopsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bjorn Oskarsson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Bjorn E. Oskarsson</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Neurodegenerative Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699451
org study id: 12-004718
nct id: NCT01699451
lead sponsor: 
has dmc: No
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.
observational model: Other
time perspective: Prospective
measure: Repository sample collection
time frame: once
This study will establish a repository of stored DNA, RNA, monocyte, lymphocyte and skin
      fibroblast samples from people with ALS and ALS-FTD, subjects with a family history of ALS
      who do not have ALS or ALS-FTD, and subjects with no personal history of ALS or dementia, to
      support future translational and basic research studies on ALS and related neurodegenerative
      disorders.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bjorn Oskarsson, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Bjorn E. Oskarsson
investigator title: PI
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Neurodegenerative Diseases
sharing ipd: No