<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/NCT03279445</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 17-0998</org_study_id>
    <nct_id>NCT03279445</nct_id>
  </id_info>
  <brief_title>Parkinson's Disease in African American and Caucasian Patients</brief_title>
  <official_title>Characteristics of African American People With Parkinson's Disease: A Hospital Based Study at the University of Chicago of the African American Community in Chicago's South Side</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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>
      More than 10 million people worldwide are living with Parkinson's disease (PD). While the&#xD;
      actual number of African American (or Black) patients with PD is unknown, it is clear that&#xD;
      there are racial disparities in the access to health care, diagnosis, treatment and survival&#xD;
      of PD. The lack of clear knowledge on the possibly lower PD prevalence among African&#xD;
      Americans compared to Caucasians further calls for more research in this field. The&#xD;
      University of Chicago Medicine is an ideal facility to study this topic, due to its location&#xD;
      on the South Side of Chicago with a large African American (or Black) population. By&#xD;
      analyzing the demographics, socioeconomics and clinical features of PD patients in our Center&#xD;
      for Research Informatics in African American (or Black) patients compared to the Caucasians&#xD;
      of similar geographical area, the investigators aim to work toward a better understanding of&#xD;
      the unique features of PD in American American (or Black) population, which might help&#xD;
      improve the healthcare among this population in the Chicago and possibly nationwide as well.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first portion of the study will be a large medical electronic data based search and&#xD;
      analysis of patients with PD on demographics, socioeconomic status and clinical features of&#xD;
      PD patients. Specifically, we will retrospectively identify PD patients on both races from&#xD;
      the electronic medical database spanned from 1/1/2006 to 10/31/2017 and compared&#xD;
      demographics, socioeconomic status (educations, incomes and insurances), co-morbidities (all&#xD;
      categories, including mood, cognition and psychosis), treatment (medications for parkinsonism&#xD;
      and major non-motor symptoms, and frequency and locations of healthcare) and survival, and&#xD;
      identified factors associated with medication usage and survival.&#xD;
&#xD;
      The second portion was designed to collect more detailed clinical assessments for information&#xD;
      not available in the database and blood draws for genetic or candidate gene mutation&#xD;
      analysis. Unfortunately, this part of the study could not be carried out due to the COVID-19&#xD;
      pandemic, which began shortly after completion of the first portion of the study. These&#xD;
      assessments and analyses would have helped determine if there are significant differences in&#xD;
      the clinical and genetic profiles between the African American (or Black) and Caucasian PD&#xD;
      patients that account for their differences in clinical features and PD prevalence in these&#xD;
      two populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Actual">April 10, 2021</completion_date>
  <primary_completion_date type="Actual">April 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disparities in diagnosis, treatment and survival between Black and White Parkinson patients</measure>
    <time_frame>Through study completion, an average of one year</time_frame>
    <description>We will compare Black/AA and White PD patients on demographics, socioeconomic status (education, income, and insurance), co-morbidities, treatment (medications for parkinsonism and major non-motor symptoms, and frequency and locations of healthcare) and survival, and identify factors associated with medication usage and survival.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2033</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>African American</arm_group_label>
    <description>Patient of African American race</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caucasian</arm_group_label>
    <description>Patient of Caucasian race</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      As described in the Study Description above for details on study design. Two tubes of blood&#xD;
      of 8 ml each will be obtained from patients for future genetic testing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Parkinson's patients of either African American (or Black) or Caucasian race.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  15 years and older, confirmed diagnosis of PD, African American (or Black) or&#xD;
             Caucasian race&#xD;
&#xD;
        Exclusion Criteria: Non-PD&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tao Xie, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Xie T, Liao C, Lee D, Yu H, Padmanaban M, Kang W, Johnson J, Alshaikh J, Yuen C, Burns M, Chiu BC. Disparities in diagnosis, treatment and survival between Black and White Parkinson patients. Parkinsonism Relat Disord. 2021 Jun;87:7-12. doi: 10.1016/j.parkreldis.2021.04.013. Epub 2021 Apr 21.</citation>
    <PMID>33905958</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03279445
org study id: IRB 17-0998
nct id: NCT03279445
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
More than 10 million people worldwide are living with Parkinson's disease (PD). While the
      actual number of African American (or Black) patients with PD is unknown, it is clear that
      there are racial disparities in the access to health care, diagnosis, treatment and survival
      of PD. The lack of clear knowledge on the possibly lower PD prevalence among African
      Americans compared to Caucasians further calls for more research in this field. The
      University of Chicago Medicine is an ideal facility to study this topic, due to its location
      on the South Side of Chicago with a large African American (or Black) population. By
      analyzing the demographics, socioeconomics and clinical features of PD patients in our Center
      for Research Informatics in African American (or Black) patients compared to the Caucasians
      of similar geographical area, the investigators aim to work toward a better understanding of
      the unique features of PD in American American (or Black) population, which might help
      improve the healthcare among this population in the Chicago and possibly nationwide as well.
The first portion of the study will be a large medical electronic data based search and
      analysis of patients with PD on demographics, socioeconomic status and clinical features of
      PD patients. Specifically, we will retrospectively identify PD patients on both races from
      the electronic medical database spanned from 1/1/2006 to 10/31/2017 and compared
      demographics, socioeconomic status (educations, incomes and insurances), co-morbidities (all
      categories, including mood, cognition and psychosis), treatment (medications for parkinsonism
      and major non-motor symptoms, and frequency and locations of healthcare) and survival, and
      identified factors associated with medication usage and survival.

      The second portion was designed to collect more detailed clinical assessments for information
      not available in the database and blood draws for genetic or candidate gene mutation
      analysis. Unfortunately, this part of the study could not be carried out due to the COVID-19
      pandemic, which began shortly after completion of the first portion of the study. These
      assessments and analyses would have helped determine if there are significant differences in
      the clinical and genetic profiles between the African American (or Black) and Caucasian PD
      patients that account for their differences in clinical features and PD prevalence in these
      two populations.
observational model: Cohort
time perspective: Retrospective
measure: Disparities in diagnosis, treatment and survival between Black and White Parkinson patients
time frame: Through study completion, an average of one year
description: We will compare Black/AA and White PD patients on demographics, socioeconomic status (education, income, and insurance), co-morbidities, treatment (medications for parkinsonism and major non-motor symptoms, and frequency and locations of healthcare) and survival, and identify factors associated with medication usage and survival.
arm group label: African American
description: Patient of African American race
arm group label: Caucasian
description: Patient of Caucasian race
As described in the Study Description above for details on study design. Two tubes of blood
      of 8 ml each will be obtained from patients for future genetic testing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 100 Years
healthy volunteers: No
last name: Tao Xie, MD, PhD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
citation: Xie T, Liao C, Lee D, Yu H, Padmanaban M, Kang W, Johnson J, Alshaikh J, Yuen C, Burns M, Chiu BC. Disparities in diagnosis, treatment and survival between Black and White Parkinson patients. Parkinsonism Relat Disord. 2021 Jun;87:7-12. doi: 10.1016/j.parkreldis.2021.04.013. Epub 2021 Apr 21.
PMID: 33905958
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No