<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/NCT04496973</url>
  </required_header>
  <id_info>
    <org_study_id>1535874</org_study_id>
    <nct_id>NCT04496973</nct_id>
  </id_info>
  <brief_title>University of Delaware Parkinson's Disease Registry</brief_title>
  <official_title>University of Delaware Participant Recruitment Registry for Parkinson's Disease Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Delaware</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this Parkinson's Disease Registry is to assist with recruitment of willing&#xD;
      participants into future Parkinson's disease research studies at the University of Delaware.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is an urgent need for Parkinson's Disease research due to its increasing global&#xD;
      prevalence. Participant recruitment is a significant challenge to the success of Parkinson's&#xD;
      disease research and we need your help more than ever in moving the field forward and&#xD;
      improving the lives of people who have Parkinson's disease. Recruitment of study participants&#xD;
      can be facilitated by maintaining registries of people who agree to be contacted for future&#xD;
      studies.&#xD;
&#xD;
      The purpose of the University of Delaware Participant Recruitment Registry for Parkinson's&#xD;
      Disease Research is to create a registry that includes the contact information and basic&#xD;
      health information pertaining the participant's diagnosis of Parkinson's disease. The&#xD;
      registry will streamline recruitment and enrollment in a variety of research studies focusing&#xD;
      on topics such as, but not limited to: brain changes in Parkinson's disease, balance and gait&#xD;
      in Parkinson's disease, exercise and its effect on motor function.&#xD;
&#xD;
      To be in the registry individuals must have a clinical diagnosis of Parkinson's Disease, have&#xD;
      an interest in participating in research studies, and be willing to allow the Parkinson's&#xD;
      Disease Team access to their medical history from their medical provider(s).&#xD;
&#xD;
      To become a member of this registry, primary information including contact information and&#xD;
      some general medical information from a health provider are needed. Medical information will&#xD;
      be evaluated to confirm Parkinson's disease diagnosis and to determine if a potential&#xD;
      participant is eligible to become a member of the registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Parkinson's Disease Diagnosis</measure>
    <time_frame>Once a year, at the beginning of the year</time_frame>
    <description>By following up once a year, we will evaluate a participant's medical history to validate a diagnosis of Parkinson's Disease. A confirmed diagnosis of Parkinson's Disease is a criteria for continuing to be a part of the registry.</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Parkinson Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who have a clinical diagnosis of Parkinson's disease and are interested in&#xD;
        participating in Parkinson's disease research studies University of Delaware.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individual 21 years old or older&#xD;
&#xD;
          -  A clinical diagnosis of Parkinson's disease&#xD;
&#xD;
          -  Interest in participating in one or more investigator-led research studies at the&#xD;
             University of Delaware&#xD;
&#xD;
          -  Willingness to allow the registry team to access to the medical history from the&#xD;
             medical provider(s) that would confirm a clinical diagnosis of Parkinson's disease and&#xD;
             provide basic health information that facilitate participant-study matching&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with a clinical diagnosis of parkinsonism that is not considered primary&#xD;
             (e.g. vascular parkinsonism) or an atypical parkinsonian syndrome (e.g., progressive&#xD;
             supranuclear palsy, multiple system atrophy, corticobasal degeneration etc.)&#xD;
&#xD;
          -  Clinical diagnosis of dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Roxana Burciu, PhD</last_name>
    <phone>302-831-3066</phone>
    <email>rgburciu@udel.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roxana Burciu, PhD</last_name>
      <phone>302-831-3066</phone>
      <email>rgburciu@udel.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Delaware</investigator_affiliation>
    <investigator_full_name>Roxana Burciu</investigator_full_name>
    <investigator_title>Roxana Burciu, PhD</investigator_title>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT04496973
org study id: 1535874
nct id: NCT04496973
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this Parkinson's Disease Registry is to assist with recruitment of willing
      participants into future Parkinson's disease research studies at the University of Delaware.
There is an urgent need for Parkinson's Disease research due to its increasing global
      prevalence. Participant recruitment is a significant challenge to the success of Parkinson's
      disease research and we need your help more than ever in moving the field forward and
      improving the lives of people who have Parkinson's disease. Recruitment of study participants
      can be facilitated by maintaining registries of people who agree to be contacted for future
      studies.

      The purpose of the University of Delaware Participant Recruitment Registry for Parkinson's
      Disease Research is to create a registry that includes the contact information and basic
      health information pertaining the participant's diagnosis of Parkinson's disease. The
      registry will streamline recruitment and enrollment in a variety of research studies focusing
      on topics such as, but not limited to: brain changes in Parkinson's disease, balance and gait
      in Parkinson's disease, exercise and its effect on motor function.

      To be in the registry individuals must have a clinical diagnosis of Parkinson's Disease, have
      an interest in participating in research studies, and be willing to allow the Parkinson's
      Disease Team access to their medical history from their medical provider(s).

      To become a member of this registry, primary information including contact information and
      some general medical information from a health provider are needed. Medical information will
      be evaluated to confirm Parkinson's disease diagnosis and to determine if a potential
      participant is eligible to become a member of the registry.
observational model: Cohort
time perspective: Prospective
measure: Parkinson's Disease Diagnosis
time frame: Once a year, at the beginning of the year
description: By following up once a year, we will evaluate a participant's medical history to validate a diagnosis of Parkinson's Disease. A confirmed diagnosis of Parkinson's Disease is a criteria for continuing to be a part of the registry.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: No
last name: Roxana Burciu, PhD
phone: 302-831-3066
email: rgburciu@udel.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Delaware
investigator full name: Roxana Burciu
investigator title: Roxana Burciu, PhD
mesh term: Parkinson Disease
sharing ipd: No