Parkinson's Disease and Parkinsonism
Conditions
Keywords
Parkinson's, Genetics, PD Genetics
Brief summary
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).
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.
Interventions
Counseling provided to participant by site clinician/physician/genetic counselor.
Sponsors
Fulgent Laboratories
Indiana University
The Parkinson Study Group
Navitas Clinical Research, Inc
Parkinson's Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of genetic testing and counseling | up to 24 weeks | The total number of participants who receive genetic testing and counseling. |
| Impact Evaluation | up to 6 months | The impact of knowledge gained by people with Parkinson's by assessing returned survey responses regarding their behavior and follow-up to clinical care after receipt of genetic counseling. |
| Satisfaction Comparison | up to 6 months | Differences in satisfaction of receiving genetic test results and genetic counseling by enrolling site (clinician/genetic counselor) or centralized counseling group using the Clinical Genetic Counseling Satisfaction Score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that enroll in precision medicine trials | up to 12 months | Number of participants that enroll in precision medicine trials |
| Time it takes between first contact to the return of genetic test results | up to 12 months | Number of weeks it takes between participant consent to return of genetic test results. |
Countries
United States
Outcome results
None listed