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Novel Nanosensor Array for Detection of Volatile Biomarkers From Skin in Multiple Sclerosis (Nano-Skin-MS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074629
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Ariel Miller, Carmel Medical Center

Brief Summary:
Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young adults, with onset usually at the age 20-40 years. The disease is characterized by two main phenotypes: Relapse-Remitting MS (RR-MS) and Primary Progressive MS (PP-MS). RR-MS is the most common type of disease, for long-term management of the disease patients are treated with immunomodulatory drugs (IMD) which reduce disease activity. Response to therapy varies among patients. Presently there are no biomarkers available for diagnosis and routine follow-up of MS. Many MS patients suffer from unexpected relapsing episodes that influence dramatically their mental and physical conditions, with high stress levels, tremors, motoric disabilities, blindness and more. Therefore, early target treatment in relapse episodes is crucial, yet sufficient tools for predicting and identifying early symptoms of an upcoming relapse episode are not available. The investigators have most recently shown that breath VOCs can be used to classify among MS and non-MS patients. The major aims of the current proposal is to study the plausibility of skin based VOCs as biomarkers for MS diagnosis and To Identify and characterize skin-based VOCs as biomarkers of the clinical relapse and disease activity.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Diagnostic Test: Diagnosis, skin volatile organic compounds (VOCs) Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Novel Nanosensor Array for Detection of Volatile Biomarkers From Skin in Multiple Sclerosis
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Skin related VOCs collected by Polydimethylsiloxane patch
The skin related VOCs will be collected by "off-line" method using Polydimethylsiloxane (PDMS) patches from different body locations for sensor system and\or GC-MS analysis
Diagnostic Test: Diagnosis, skin volatile organic compounds (VOCs)
The skin related VOCs will be collected by "off-line" method using Polydimethylsiloxane (PDMS) patches from different body locations for sensor system and\or GC-MS analysis




Primary Outcome Measures :
  1. Volatile organic compounds (VOCs) in skin [ Time Frame: 3 years ]
    Identification of volatile organic compounds in skin that differentiate individuals with MS from healthy individuals.


Secondary Outcome Measures :
  1. Volatile biomarkers for disease monitoring [ Time Frame: 3 years ]
    Identification of volatile organic compounds in skin as MS markers for disease activity relapse vs. remission from.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Individuals willing and able to give informed consent

MS group:

Male or females diagnosed with MS Age 18-75 years

Control subjects:

Healthy volunteers: individuals that do not have MS or any other condition that is defined as "autoimmune"

Exclusion Criteria:

  1. Pregnant women
  2. Presence of a serious infectious disease (e.g. HIV, viral hepatitis and similar contagious diseases).

Withdrawal criteria:

  1. Any new clinical information that is not consistent with inclusion criteria.
  2. Technical problems in the performance of the tests.

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): NCT04074629


Contacts
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Contact: Ariel Miller +9728250851 milleras@netvision.net.il
Contact: lea Marmor +9728250747 leam@technion.ac.il

Locations
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Israel
Ariel Miller Recruiting
Haifa, Israel, 34362
Contact: Ariel Miller    +9728250851    milleras@netvision.net.il   
Sponsors and Collaborators
Carmel Medical Center
Technion, Israel Institute of Technology
Investigators
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Principal Investigator: Ariel Miller Multiple Sclerosis Clinc, Carmel Medical Center

Publications:

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Responsible Party: Ariel Miller, Director of Multiple Sclerosis & Brain Research Center, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT04074629    
Other Study ID Numbers: CMC-18-0177-CTIL
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019

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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 Ariel Miller, Carmel Medical Center:
Multiple Sclerosis
Skin volatile organic compounds (VOCs)
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases