Parkinson DiseaseNCT03775447
Fox BioNet Project: ECV-003
An observational study of Parkinson Disease, run by Michael J. Fox Foundation for Parkinson's Research at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Lumbar Puncture
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Apr 2019to 18 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
Official title: FoxBioNet: ECV (Extracellular Vesicle) 003
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
Read the 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
- Conditions
- Parkinson Disease
- Being tested
- Lumbar Puncture
- Keywords
- Parkinson's Disease, Biomarker, LRRK2, CSF
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar PunctureProcedure or surgery
Also called Biofluid Samplings: Blood
Lumbar Puncture for collection of Cerebrospinal Fluids
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lumbar Puncture | |
| Healthy Control (HC) Subjects | • Male or female age 18 years or older at Screening. Receives: Procedure: Lumbar Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used
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).
Measured: 1 year
Secondary outcomes (7)
Power analysis to guide future research
Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes
Measured: 1 year
Time from IRB submission to approval by central IRB
Time from IRB submission to approval by central IRB
Measured: 3 months
Time from central IRB approval to site approval
Time from central IRB approval to site approval (for those sites requiring administrative review)
Measured: 3 months
Time from site selection to contract full execution
Time from site selection to contract full execution
Measured: 4 months
Completion of Recruitment
Time from site activation to completion of recruitment.
Measured: 6 months
Proportion of samples conforming to collection
Proportion of samples conforming to collection, processing and shipping protocols.
Measured: 6 months
Retention
Proportion of participants agreeing to be contacted for future Fox BioNet protocols
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start23 Apr 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Indiana University, University of Rochester
- Responsible party
- Principal investigator, Connie Marras, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775447
- Sponsor's protocol ID
- ECV-003
- Status last verified
- Aug 2021
- First submitted
- 20 Nov 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FoxBioNet: ECV (Extracellular Vesicle) 003
- ClinicalTrials.gov ID
- NCT03775447
- Acronym / sponsor ID
- ECV-003
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Biomarker, LRRK2, CSF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Indiana University, University of Rochester
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Patients | – | Procedure: Lumbar Puncture* 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 Control (HC) Subjects | – | Procedure: Lumbar Puncture• Male or female age 18 years or older at Screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- •Male or female age 18 years or older at Screening.
Key exclusion criteria (11 listed)
- 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.
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar PunctureAlso: Biofluid Samplings: BloodLumbar Puncture for collection of Cerebrospinal Fluids | Procedure or surgery | Healthy Control (HC) Subjects, Parkinson's Disease Patients |
Primary outcome
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).
7 secondary outcomes
Power analysis to guide future research
Time frame: 1 year
Time from IRB submission to approval by central IRB
Time frame: 3 months
Time from central IRB approval to site approval
Time frame: 3 months
Time from site selection to contract full execution
Time frame: 4 months
Completion of Recruitment
Time frame: 6 months
Proportion of samples conforming to collection
Time frame: 6 months
Retention
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Michael J. Fox Foundation for Parkinson's Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.