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Parkinson's Foundation PD GENEration Genetic Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04994015
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : July 14, 2023
Sponsor:
Collaborators:
Indiana University
Fulgent Genetics
The Parkinson Study Group
Information provided by (Responsible Party):
Parkinson's Foundation

Study Description
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Brief Summary:
Development of a central repository for PD-related genomic data for future research.

Condition or disease Intervention/treatment
Parkinson's Disease Device: Lab Assay for seven genetic variants for Parkinson's Disease

Detailed Description:
The purpose of this study is to develop a central repository for PD-related genomic data by individuals who consent to deposit their data and bank their residual DNA obtained through clinical genetic testing for future research use.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 30 Days
Official Title: Parkinson's Foundation PD GENEration Genetic Registry
Actual Study Start Date : December 20, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Lab Assay for seven genetic variants for Parkinson's Disease
    Counseling provided to participant by site clinician/physician/genetic counselor.

Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of Parkinson's related genetic mutations in an convenience cohort [ Time Frame: 6 months ]
    Identify people with Parkinson's who have genetic mutations to advance basic science and clinical research.

  2. Educating people with Parkinson's of their genetic mutation status through genetic testing and counseling [ Time Frame: 6 months ]
    People who are informed of their genetic status may be empowered to learn more about their disease and participant in clinical research.


Biospecimen Retention:   Samples With DNA
Isolated DNA from buccal swab or whole blood.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any person with probable diagnosis of Parkinson's disease according to the Movement Disorders Society criteria.
Criteria

Inclusion Criteria:

  • Study Population 1: PWP (open for recruitment)

    1. Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
    2. Willingness to undergo genetic testing, and choose to be informed of genetic testing results for GBA, LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
    3. Capacity to give full informed consent in writing or electronically, and have read and signed the informed consent forms (ICFs) based on site clinician's determination.
    4. Able to perform study activities (including completion of either online, in-person or paper surveys).

Study Population 2: People at risk of developing PD (not open for recruitment)

1. Family members of Study Population 1 may be invited to participate in the study if confirmatory genetic testing is deemed necessary by the genetic testing laboratory.

Exclusion Criteria:

  1. Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
  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.
  5. Under the age of 18
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04994015


Contacts
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Contact: Kamalini Ghosh, MS 1-800-473-4636 kghosh@parkinson.org

Locations
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United States, Arizona
MD First Research Recruiting
Chandler, Arizona, United States, 85286
Contact: Sean Guardado    480-508-1039    sguardado@brainandspineaz.com   
Principal Investigator: Hemant Pandey, MD         
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Ruby Rendin       ruby.rendon@dignityhealth.org   
Principal Investigator: Holly Shill, MD         
United States, Arkansas
University of Arkansas Recruiting
Fayetteville, Arkansas, United States, 72701
Contact: Rohit Dhall, MD    501-686-7236    RDhall@uams.edu   
Principal Investigator: Rohit Dhall, MD         
United States, California
University of California San Diego (UCSD) Recruiting
La Jolla, California, United States, 92093
Contact: Lisa Damron    858-822-5873    ldamron@health.ucsd.edu   
Principal Investigator: Irene Litvan, MD         
University of California San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94143
Contact: Aaron Daley       aaron.daley@ucsf.edu   
Principal Investigator: Jill Ostrem, MD         
United States, Florida
Aventura Neurology - Visionary Investigators Network Recruiting
Aventura, Florida, United States, 33180
Contact: Jonathan Palmquist    833-732-2484    Jpalmquist@vintrials.com   
Principal Investigator: Julie Schwartzbard, MD         
Parkinson's Disease & Movement Disorder Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Contact: Claire Hennum       chennum@ParkinsonsCenter.org   
Principal Investigator: Stuart Isaacson, MD         
University of Miami Recruiting
Miami, Florida, United States, 33131
Contact: Lucila Hernandez    305-243-1160      
Principal Investigator: Carlos Singer, MD         
Principal Investigator: Ihtsham Haq, MD         
Sub-Investigator: Henry Moore, MD         
United States, Georgia
Morehouse College Recruiting
Atlanta, Georgia, United States, 30314
Contact: Sherline Sauveur       parkinsonsstudy@msm.edu   
Principal Investigator: Chantale Branson, MD         
United States, Illinois
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Marc Rosenbaum    312-563-0665    Marc_Rosenbaum@rush.edu   
Principal Investigator: Deborah Hall, MD         
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Max Greene       max.galarce@northwestern.edu   
Principal Investigator: Niccolo Mencacci, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lauren Perrey-Moore       lperrey@iupui.edu   
Principal Investigator: Elizabeth Zauber, MD         
United States, Massachusetts
St. Elizabeth's Medical Center Recruiting
Boston, Massachusetts, United States, 02136
Contact: Kaitlyn Ramsey       kaitlyn.ramsey@steward.org   
Principal Investigator: Eleni Okeanis Vaou, MD         
Beth Israel Deaconess Medical Center (BIDMC) Recruiting
Boston, Massachusetts, United States, 02215
Contact: Hannah Babcock       hbabcock@bidmc.harvard.edu   
Principal Investigator: David Simon, MD         
United States, Minnesota
Struthers Parkinson's Center - HealthPartners Park Nicollet Recruiting
Golden Valley, Minnesota, United States, 55427
Contact: Sherry Niesen, RN    952-993-2245    sherry.niesen@parknicollet.com   
Principal Investigator: Martha Nance, MD         
United States, Washington
Inland Northwest Research Recruiting
Spokane, Washington, United States, 99202
Contact: Melissa Bixby Sanchez, MS       mbixby@inwresearch.com   
Principal Investigator: Jason Aldred, MD         
Sponsors and Collaborators
Parkinson's Foundation
Indiana University
Fulgent Genetics
The Parkinson Study Group
Investigators
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Principal Investigator: James Beck, PhD Parkinson's Foundation
  Study Documents (Full-Text)

Documents provided by Parkinson's Foundation:
Informed Consent Form  [PDF] April 26, 2021

More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Parkinson's Foundation
ClinicalTrials.gov Identifier: NCT04994015    
Other Study ID Numbers: PDGENE-PF
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases