NCT03775447已完成不适用
FoxBioNet: ECV (Extracellular Vesicle) 003
Michael J. Fox Foundation for Parkinson's Research3 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used
研究概览
简要总结
The goal of this study is to optimize pre-analytical cerebrospinal fluid (CSF) extracellular vesicle isolation protocols for increasing the detection of LRRK2 activity in human CSF
详细描述
Specific aims to accomplish this objective are:
PRIMARY OBJECTIVES:
- To evaluate a series of extracellular vesicle isolation methods for their ability to enrich for LRRK2 and increase the detection of LRRK2 in CSF samples.
- To compare the measurements of LRRK2, p1292 LRRK2, Rabs and pRabs from the ECVs isolated using each method.
- To assess the inter-lab reliability of each method
SECONDARY OBJECTIVES
- To assess the ability of the network of sites to efficiently conduct a study involving biosample collection for PD research. Efficiency will be assessed using measures of the time taken to meet specific milestones within the study
- To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols.
- To gauge the willingness of participants to participate in subsequent Fox BioNet studies
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's Disease Patients:
- •A diagnosis of Parkinson's disease in the opinion of the enrolling investigator
- •Disease duration: any
- •Male or female age 18 years or older at time of PD diagnosis.
- •Healthy Controls:
- •Male or female age 18 years or older at Screening.
排除标准
- •Parkinson's Disease Patients:
- •Inability to provide informed consent
- •Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
- •Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- •Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.
- •Healthy Controls:
- •Inability to provide informed consent
- •Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
- •Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- •Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.
- •Currently pregnant (female participants)
结局指标
主要结局
degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used
时间窗: 1 year
For methods involving immunoprecipitation: Increase in peptide spectral matches on mass spectrometry For methods amenable to antibody-based detection: increase in LRRK2 intensity on Western blotting (arbitrary units).
次要结局
- Completion of Recruitment(6 months)
- Time from IRB submission to approval by central IRB(3 months)
- Power analysis to guide future research(1 year)
- Time from site selection to contract full execution(4 months)
- Time from central IRB approval to site approval(3 months)
- Proportion of samples conforming to collection(6 months)
- Retention(1 year)
研究者
Connie Marras
Neurologist at Toronto Western Hospital Movement Disorders Centre
University Health Network, Toronto
研究点 (3)
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