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| Name | Class |
|---|---|
| Fulgent Laboratories | UNKNOWN |
| Indiana University | OTHER |
| The Parkinson Study Group | NETWORK |
| Navitas Clinical Research, Inc |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Site-Based Genetic Counseling | Active Comparator | Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site. |
|
| Centralized Genetic Counseling | Active Comparator | Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab Assay for seven genetic variants for Parkinson's Disease | Device | Counseling provided to participant by site clinician/physician/genetic counselor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of genetic testing and counseling | The total number of participants who receive genetic testing and counseling. | up to 24 weeks |
| Impact Evaluation | 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. | up to 6 months |
| Satisfaction Comparison | 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. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that enroll in precision medicine trials | Number of participants that enroll in precision medicine trials | up to 12 months |
| Time it takes between first contact to the return of genetic test results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy N Alcalay, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| University of California San Diego (UCSD) |
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| Label | URL |
|---|---|
| For more information and to enroll, please visit the website. | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2020 | Sep 9, 2020 |
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| UNKNOWN |
All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
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| Lab Assay for seven genetic variants for Parkinson's Disease | Device | Counseling provided to participant by centralized genetic counseling group at Indiana University. |
|
Number of weeks it takes between participant consent to return of genetic test results.
| up to 12 months |
| La Jolla |
| California |
| 92093 |
| United States |
| University of Miami | Fort Lauderdale | Florida | 33308 | United States |
| Cleveland Clinic Florida-Weston | Weston | Florida | 33331 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02129 | United States |
| Health Partners/Park Nicollet: Struthers Parkinson's Center | Minneapolis | Minnesota | 55427 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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