Clinical trial NCT04057794: PDGeneration: Mapping the Future of Parkinson's Disease
Official title: Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson's Disease and Parkinsonism
Keywords: Parkinson's
Genetics
PD Genetics
Lead sponsor: Parkinson's Foundation
Sponsor class: OTHER
Collaborators: name: Fulgent Laboratories
name: Indiana University
name: The Parkinson Study Group
name: Navitas Clinical Research, Inc
First posted: 2019-08-15
Enrollment: 1982
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of genetic testing and counseling
timeFrame: up to 24 weeks
measure: Impact Evaluation
timeFrame: up to 6 months
measure: Satisfaction Comparison
timeFrame: up to 6 months
Secondary outcomes:
measure: Number of participants that enroll in precision medicine trials
timeFrame: up to 12 months
measure: Time it takes between first contact to the return of genetic test results
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego (UCSD)
state: California
city: Fort Lauderdale
country: United States
facility: University of Miami
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida-Weston
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Health Partners/Park Nicollet: Struthers Parkinson's Center
state: Minnesota
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Columbia University
name: Roy N Alcalay, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: