- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03279445
Parkinson's Disease in African American and Caucasian Patients
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
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 15 years and older, confirmed diagnosis of PD, African American (or Black) or Caucasian race
Exclusion Criteria: Non-PD
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
African American
Patient of African American race
|
Two tubes of blood samples for genetic testing.
|
|
Caucasian
Patient of Caucasian race
|
Two tubes of blood samples for genetic testing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disparities in diagnosis, treatment and survival between Black and White Parkinson patients
Time Frame: Through study completion, an average of one year
|
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.
|
Through study completion, an average of one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The difference in genetic profiles in these two populations with PD
Time Frame: Through study completion - up to two years
|
As above (drawing blood samples and running genetic tests)
|
Through study completion - up to two years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tao Xie, MD, PhD, University of Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 17-0998
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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