PDGeneration: Mapping the Future of Parkinson's Disease
NCT ID: NCT04057794
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1982 participants
INTERVENTIONAL
2019-08-15
2025-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Site-Based Genetic Counseling
Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site.
Lab Assay for seven genetic variants for Parkinson's Disease
Counseling provided to participant by site clinician/physician/genetic counselor.
Centralized Genetic Counseling
Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University.
Lab Assay for seven genetic variants for Parkinson's Disease
Counseling provided to participant by centralized genetic counseling group at Indiana University.
Interventions
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Lab Assay for seven genetic variants for Parkinson's Disease
Counseling provided to participant by site clinician/physician/genetic counselor.
Lab Assay for seven genetic variants for Parkinson's Disease
Counseling provided to participant by centralized genetic counseling group at Indiana University.
Eligibility Criteria
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Inclusion Criteria
2. Willingness to undergo genetic testing, and choose to be informed of genetic testing results for Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
3. Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.
4. Able to perform study activities (including completion of either online, in-person or paper surveys).
5. Individuals must speak and understand the language of the informed consent.
Exclusion Criteria
2. Individuals who have received a blood transfusion within the past 3 months.
3. Individuals who have active hematologic malignancies such as lymphoma or leukemia.
4. Individuals who have had a bone marrow transplant within the past 5 years.
18 Years
ALL
No
Sponsors
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Fulgent Laboratories
UNKNOWN
Indiana University
OTHER
The Parkinson Study Group
NETWORK
Navitas Clinical Research, Inc
UNKNOWN
Parkinson's Foundation
OTHER
Responsible Party
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Principal Investigators
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Roy N Alcalay, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
University of California San Diego (UCSD)
La Jolla, California, United States
University of Miami
Fort Lauderdale, Florida, United States
Cleveland Clinic Florida-Weston
Weston, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Health Partners/Park Nicollet: Struthers Parkinson's Center
Minneapolis, Minnesota, United States
Beth Israel Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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For more information and to enroll, please visit the website.
Other Identifiers
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PDGene-01
Identifier Type: -
Identifier Source: org_study_id
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