- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04994015
Parkinson's Foundation PD GENEration Genetic Registry
July 12, 2023 updated by: Parkinson's Foundation
Development of a central repository for PD-related genomic data for future research.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
15000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kamalini Ghosh, MS
- Phone Number: 1-800-473-4636
- Email: kghosh@parkinson.org
Study Locations
-
-
Arizona
-
Chandler, Arizona, United States, 85286
- Recruiting
- MD First Research
-
Contact:
- Sean Guardado
- Phone Number: 480-508-1039
- Email: sguardado@brainandspineaz.com
-
Principal Investigator:
- Hemant Pandey, MD
-
Phoenix, Arizona, United States, 85013
- Recruiting
- Barrow Neurological Institute
-
Contact:
- Ruby Rendin
- Email: ruby.rendon@dignityhealth.org
-
Principal Investigator:
- Holly Shill, MD
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72701
- Recruiting
- University of Arkansas
-
Contact:
- Rohit Dhall, MD
- Phone Number: 501-686-7236
- Email: RDhall@uams.edu
-
Principal Investigator:
- Rohit Dhall, MD
-
-
California
-
La Jolla, California, United States, 92093
- Recruiting
- University of California San Diego (UCSD)
-
Principal Investigator:
- Irene Litvan, MD
-
Contact:
- Lisa Damron
- Phone Number: 858-822-5873
- Email: ldamron@health.ucsd.edu
-
San Francisco, California, United States, 94143
- Recruiting
- University of California San Francisco (UCSF)
-
Contact:
- Aaron Daley
- Email: aaron.daley@ucsf.edu
-
Principal Investigator:
- Jill Ostrem, MD
-
-
Florida
-
Aventura, Florida, United States, 33180
- Recruiting
- Aventura Neurology - Visionary Investigators Network
-
Contact:
- Jonathan Palmquist
- Phone Number: 833-732-2484
- Email: Jpalmquist@vintrials.com
-
Principal Investigator:
- Julie Schwartzbard, MD
-
Boca Raton, Florida, United States, 33486
- Recruiting
- Parkinson's Disease & Movement Disorder Center of Boca Raton
-
Contact:
- Claire Hennum
- Email: chennum@parkinsonscenter.org
-
Principal Investigator:
- Stuart Isaacson, MD
-
Miami, Florida, United States, 33131
- Recruiting
- University of Miami
-
Principal Investigator:
- Carlos Singer, MD
-
Contact:
- Lucila Hernandez
- Phone Number: 305-243-1160
-
Principal Investigator:
- Ihtsham Haq, MD
-
Sub-Investigator:
- Henry Moore, MD
-
-
Georgia
-
Atlanta, Georgia, United States, 30314
- Recruiting
- Morehouse College
-
Principal Investigator:
- Chantale Branson, MD
-
Contact:
- Sherline Sauveur
- Email: parkinsonsstudy@msm.edu
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- Rush University
-
Principal Investigator:
- Deborah Hall, MD
-
Contact:
- Marc Rosenbaum
- Phone Number: 312-563-0665
- Email: Marc_Rosenbaum@rush.edu
-
Evanston, Illinois, United States, 60208
- Recruiting
- Northwestern University
-
Contact:
- Max Greene
- Email: max.galarce@northwestern.edu
-
Principal Investigator:
- Niccolo Mencacci, MD
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University
-
Contact:
- Lauren Perrey-Moore
- Email: lperrey@iupui.edu
-
Principal Investigator:
- Elizabeth Zauber, MD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center (BIDMC)
-
Principal Investigator:
- David Simon, MD
-
Contact:
- Hannah Babcock
- Email: hbabcock@bidmc.harvard.edu
-
Boston, Massachusetts, United States, 02136
- Recruiting
- St. Elizabeth's Medical Center
-
Contact:
- Kaitlyn Ramsey
- Email: kaitlyn.ramsey@steward.org
-
Principal Investigator:
- Eleni Okeanis Vaou, MD
-
-
Minnesota
-
Golden Valley, Minnesota, United States, 55427
- Recruiting
- Struthers Parkinson's Center - HealthPartners Park Nicollet
-
Principal Investigator:
- Martha Nance, MD
-
Contact:
- Sherry Niesen, RN
- Phone Number: 952-993-2245
- Email: sherry.niesen@parknicollet.com
-
-
Washington
-
Spokane, Washington, United States, 99202
- Recruiting
- Inland Northwest Research
-
Contact:
- Melissa Bixby Sanchez, MS
- Email: mbixby@inwresearch.com
-
Principal Investigator:
- Jason Aldred, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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.
Description
Inclusion Criteria:
Study Population 1: PWP (open for recruitment)
- Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
- 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).
- 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.
- 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:
- 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.
- Individuals who have received a blood transfusion within the past 3 months.
- Individuals who have active hematologic malignancies such as lymphoma or leukemia.
- Individuals who have had a bone marrow transplant within the past 5 years.
- Under the age of 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Beck, PhD, Parkinson's Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2020
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
July 29, 2021
First Submitted That Met QC Criteria
July 29, 2021
First Posted (Actual)
August 6, 2021
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDGENE-PF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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