Clinical trial NCT03170063: FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)
Official title: FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort) (SAVE001)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Alpha-Synuclein
Biomarker
Lead sponsor: Michael J. Fox Foundation for Parkinson's Research
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Indiana University
name: ICON Clinical Research Limited
First posted: 2017-05-30
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 Parkinson's Disease Subjects, and 20 Healthy Controls. Potential participants will be identified by the study sites through their patient population or through Fox Trial Finder.

Brief summary: The overall objective of this study is to compare the performance of available oligomeric and phosphorylated a-synuclein assay in cerebrospinal fluid and blood.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

Parkinson's Disease Subjects

* Patients must meet the MDS criteria for Parkinson's disease.
* Disease duration: any
* Male or female age 30 years or older at time of PD diagnosis.

Control Subjects

* Male or female age 30 years or older at Screening.

Exclusion Criteria:

Parkinson's Disease Subjects

* 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.

Control Subjects

* 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.
* The presence of rest tremor, bradykinesia or rigidity.
* The presence of any other neurological sign that in the opinion of the site investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear gaze palsy)

Primary outcomes:
measure: Oligomeric and PS129 α-syn levels
timeFrame: 3 Months
Secondary outcomes:
measure: Time from IRB submission to approval by central IRB
timeFrame: 3 Months
measure: Time from central IRB approval to site approval (for those sites requiring administrative review)
timeFrame: 3 Months
measure: Time from site selection to contract full execution
timeFrame: 3 Months
measure: Time from site activation to recruitment of 10 participants
timeFrame: 3 Months
measure: Proportion of samples conforming to collection, processing and shipping protocols.
timeFrame: 3 Months
measure: Proportion of participants agreeing to be contacted for future Fox BioNet protocols
timeFrame: 3 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
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: University Health Network, Toronto
name: Connie Marras, MD
role: PRINCIPAL_INVESTIGATOR
References: