Purpose

To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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 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

  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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Site-Based Genetic Counseling
Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site.
  • Device: Lab Assay for seven genetic variants for Parkinson's Disease
    Counseling provided to participant by site clinician/physician/genetic counselor.
Active Comparator
Centralized Genetic Counseling
Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University.
  • Device: Lab Assay for seven genetic variants for Parkinson's Disease
    Counseling provided to participant by centralized genetic counseling group at Indiana University.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Patricia Brady, RN
913-588-0013
pbrady3@kumc.edu

More Details

Status
Recruiting
Sponsor
Parkinson's Foundation

Study Contact

Elizabeth U Lyda, BS
585-273-4038
elizabeth.lyda@chet.rochester.edu

Detailed Description

The purpose of this study is to evaluate how offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing for Parkinson's Disease (PD) genes to people with Parkinson's Disease impacts clinical care and potential enrollment in clinical trials. This multi-center study will assess the impact and satisfaction of the mode of genetic counseling by comparing counseling conducted by a clinician versus centralized genetic counseling conducted through Indiana University. The study will also assess knowledge gained by administering a knowledge survey pre- and post-genetic testing. All genetic test results will be returned to participants through a genetic counseling visit.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.