The overall objective of this study is to compare the performance of available oligomeric and phosphorylated a-synuclein assay in cerebrospinal fluid and blood.
Specific aims to accomplish this objective are: 1. Assess the reliability of oligomeric and phosphorylated a-synuclein concentration between two different oligomeric and three phosphorylated asynuclein assays. 2. Assess the reliability of the oligomeric and phosphorylated a-synuclein concentrations between laboratories 3. Assess the correlation of oligomeric and phosphorylated a-synuclein concentrations between cerebrospinal fluid and blood. 1.2. Secondary Objectives 1. To assess the ability of the network of pilot 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. 2. To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols. 3. To gauge the willingness of participants to participate in subsequent Fox BioNet studies
Study Type
OBSERVATIONAL
Enrollment
54
Biofluid samplings (blood and cerebrospinal fluid (CSF))
Rush University Medical Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Oligomeric and PS129 α-syn levels
CSF, serum, and plasma will be analyzed using oligomeric and pS129 assays. The outcome will be expressed as a concentration of modified (pS129 or oligomeric) synuclein or as a ratio of specific species to total synuclein levels.
Time frame: 3 Months
Time from IRB submission to approval by central IRB
To assess time taken from submission of proposal to IRB to approval by the IRB
Time frame: 3 Months
Time from central IRB approval to site approval (for those sites requiring administrative review)
To assess time taken from approval by IRB to approval by internal boards for sites.
Time frame: 3 Months
Time from site selection to contract full execution
To assess the ability of the network of pilot 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.
Time frame: 3 Months
Time from site activation to recruitment of 10 participants
Time taken from site activation to recruitment of 10 participants
Time frame: 3 Months
Proportion of samples conforming to collection, processing and shipping protocols.
To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols.
Time frame: 3 Months
Proportion of participants agreeing to be contacted for future Fox BioNet protocols
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Baylor College of Medicine
Houston, Texas, United States
To gauge the willingness of participants to participate in subsequent Fox BioNet studies
Time frame: 3 Months