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Fox BioNet Project: ECV-003

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775447
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
University Health Network, Toronto
Indiana University
Clinical Trials Coordination Center
Information provided by (Responsible Party):
Connie Marras, University Health Network, Toronto

Brief Summary:
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

Condition or disease Intervention/treatment
Parkinson Disease Procedure: Lumbar Puncture

Detailed Description:

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

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: FoxBioNet: ECV (Extracellular Vesicle) 003
Actual Study Start Date : April 23, 2019
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Other Name: Biofluid Samplings: Blood

Healthy Control (HC) Subjects
• Male or female age 18 years or older at Screening.
Procedure: Lumbar Puncture
Lumbar Puncture for collection of Cerebrospinal Fluids
Other Name: Biofluid Samplings: Blood




Primary Outcome Measures :
  1. degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used [ Time Frame: 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).


Secondary Outcome Measures :
  1. Power analysis to guide future research [ Time Frame: 1 year ]
    Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes

  2. Time from IRB submission to approval by central IRB [ Time Frame: 3 months ]
    Time from IRB submission to approval by central IRB

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

  4. Time from site selection to contract full execution [ Time Frame: 4 months ]
    Time from site selection to contract full execution

  5. Completion of Recruitment [ Time Frame: 6 months ]
    Time from site activation to completion of recruitment.

  6. Proportion of samples conforming to collection [ Time Frame: 6 months ]
    Proportion of samples conforming to collection, processing and shipping protocols.

  7. Retention [ Time Frame: 1 year ]
    Proportion of participants agreeing to be contacted for future Fox BioNet protocols


Biospecimen Retention:   Samples With DNA
Cerebro-Spinal Fluids


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 36 subjects will be enrolled to participate in this study, a combination of Parkinson Disease (PD) (any stage) and Healthy Controls in no specified proportion.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775447


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Michael J. Fox Foundation for Parkinson's Research
University Health Network, Toronto
Indiana University
Clinical Trials Coordination Center
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Responsible Party: Connie Marras, Neurologist at Toronto Western Hospital Movement Disorders Centre, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03775447    
Other Study ID Numbers: ECV-003
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Connie Marras, University Health Network, Toronto:
Parkinson's Disease
Biomarker
LRRK2
CSF
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases