Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,982
- 试验地点
- 24
- 主要终点
- Feasibility of genetic testing and counseling
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
- •Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.
- •Able to perform study activities (including completion of either online, in-person or paper surveys).
- •Individuals must speak and understand the language of the informed consent.
排除标准
- •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.
结局指标
主要结局
Feasibility of genetic testing and counseling
时间窗: up to 24 weeks
The total number of participants who receive genetic testing and counseling.
Impact Evaluation
时间窗: 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
时间窗: 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.
次要结局
- 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(up to 12 months)