- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01246336
Exploratory Study Using Nanotechnology to Detect Biomarkers of Parkinson's Disease From Exhaled Breath
October 30, 2017 updated by: Ilana Schlesinger, Rambam Health Care Campus
Exploratory Study to Detect Volatile Biomarkers of Idiopathic Parkinson's Disease and Parkinsonism From Exhaled Breath Using a Nanomedical Artificial Olfactory System.
Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available.
Exhaled breath testing may yield a "breath-print" that can be used to distinguish healthy and diseased states.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
41
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients diagnosed with Idiopathic Parkinson's disease and Parkinsonism will be included.
Description
Inclusion Criteria:
- Patients with Parkinsonism
Exclusion Criteria:
- Severe dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with parkinsonism
Patients suffering from Parkinson's disease or parkinsonism
|
no intervention
|
Healthy controls
Patients not suffering from Parkinson's disease or any other neurological disorder
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nanosensory detection
Time Frame: immediate
|
analyze combinations of nanomaterial-based sensors (organically functionalized carbon nanotubes and gold nanoparticles)
|
immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ilana Schlesinger, MD, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 21, 2010
First Submitted That Met QC Criteria
November 22, 2010
First Posted (Estimate)
November 23, 2010
Study Record Updates
Last Update Posted (Actual)
October 31, 2017
Last Update Submitted That Met QC Criteria
October 30, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMB09-0196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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