FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)


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Verified May 2017 by Connie Marras, University Health Network, Toronto

Sponsor:

Collaborators:

University Health Network, Toronto

Indiana University

ICON Clinical Research Limited

Information provided by (Responsible Party):

Connie Marras, University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03170063

First received: May 26, 2017

Last updated: May 26, 2017

Last verified: May 2017

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

Parkinson Disease Procedure: Procedure/Surgery: Biofluid samplings

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort) (SAVE001)

Primary Outcome Measures:

  • Oligomeric and PS129 α-syn levels [ Time Frame: 3 Months ]

    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.

Secondary Outcome Measures:

  • Time from IRB submission to approval by central IRB [ Time Frame: 3 Months ]

    To assess time taken from submission of proposal to IRB to approval by the IRB

  • Time from central IRB approval to site approval (for those sites requiring administrative review) [ Time Frame: 3 Months ]

    To assess time taken from approval by IRB to approval by internal boards for sites.

  • Time from site selection to contract full execution [ Time Frame: 3 Months ]

    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 from site activation to recruitment of 10 participants [ Time Frame: 3 Months ]

    Time taken from site activation to recruitment of 10 participants

  • Proportion of samples conforming to collection, processing and shipping protocols. [ Time Frame: 3 Months ]

    To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols.

  • Proportion of participants agreeing to be contacted for future Fox BioNet protocols [ Time Frame: 3 Months ]

    To gauge the willingness of participants to participate in subsequent Fox BioNet studies

Biospecimen Retention:   Samples With DNA

Cerebrospinal Fluid, whole blood, serum, and plasma

Estimated Enrollment: 50
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: August 31, 2017
Estimated Primary Completion Date: August 31, 2017 (Final data collection date for primary outcome measure)
Parkinson’s Disease Subjects

Up to 30 Parkinson’s Disease patients will be enrolled.

Procedure: Procedure/Surgery: Biofluid samplings

Biofluid samplings (blood and cerebrospinal fluid (CSF))

Healthy Controls

Up to 20 healthy controls will be enrolled.

Procedure: Procedure/Surgery: Biofluid samplings

Biofluid samplings (blood and cerebrospinal fluid (CSF))

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

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

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.

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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03170063

Rush University Medical Center
Chicago, Illinois, United States, 60612-3863
Contact: Samantha Ruehl    312-942-7391    samantha_ruehl@rush.edu   
Principal Investigator: Jennifer Goldman, MD         
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Contact: Althea Silver    617-667-9885    asilver2@bidmc.harvard.edu   
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Contact: Alison Freed    503-494-1382    freeal@ohsu.edu   
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Contact: Rachael Purri    215-829-6952    rachael.purri@uphs.upenn.edu   
Principal Investigator: Lana Chahine, MD         
Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Christine Hunter, RN    713-798-3951    chunter@bcm.edu   
Principal Investigator: Joseph Jankovic, MD         

Michael J. Fox Foundation for Parkinson’s Research

University Health Network, Toronto

Indiana University

ICON Clinical Research Limited

Principal Investigator: Connie Marras, MD University Health Network, Toronto

Responsible Party: Connie Marras, Neurologist at Toronto Western Hospital Movement Disorders Centre, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03170063     History of Changes
Other Study ID Numbers: SAVE001
Study First Received: May 26, 2017
Last Updated: May 26, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Connie Marras, University Health Network, Toronto:

Parkinson’s Disease
Alpha-Synuclein
Biomarker

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 30, 2017