NCT04074629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 16, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

August 21, 2019

Last Update Submit

December 6, 2022

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisSkin volatile organic compounds (VOCs)

Outcome Measures

Primary Outcomes (1)

  • Volatile organic compounds (VOCs) in skin

    Identification of volatile organic compounds in skin that differentiate individuals with MS from healthy individuals.

    3 years

Secondary Outcomes (1)

  • Volatile biomarkers for disease monitoring

    3 years

Study Arms (1)

Skin related VOCs collected by Polydimethylsiloxane patch

EXPERIMENTAL

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)

Interventions

Diagnosis, skin volatile organic compounds (VOCs)DIAGNOSTIC_TEST

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

Skin related VOCs collected by Polydimethylsiloxane patch

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

  • Pregnant women
  • Presence of a serious infectious disease (e.g. HIV, viral hepatitis and similar contagious diseases).
  • Withdrawal criteria:
  • Technical problems in the performance of the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ariel Miller

Haifa, 34362, Israel

Location

Related Publications (6)

  • Broza YY, Har-Shai L, Jeries R, Cancilla JC, Glass-Marmor L, Lejbkowicz I, Torrecilla JS, Yao X, Feng X, Narita A, Mullen K, Miller A, Haick H. Exhaled Breath Markers for Nonimaging and Noninvasive Measures for Detection of Multiple Sclerosis. ACS Chem Neurosci. 2017 Nov 15;8(11):2402-2413. doi: 10.1021/acschemneuro.7b00181. Epub 2017 Aug 16.

    PMID: 28768105BACKGROUND

  • Broza YY, Mochalski P, Ruzsanyi V, Amann A, Haick H. Hybrid volatolomics and disease detection. Angew Chem Int Ed Engl. 2015 Sep 14;54(38):11036-48. doi: 10.1002/anie.201500153. Epub 2015 Jul 31.

    PMID: 26235374BACKGROUND

  • Ionescu R, Broza Y, Shaltieli H, Sadeh D, Zilberman Y, Feng X, Glass-Marmor L, Lejbkowicz I, Mullen K, Miller A, Haick H. Detection of multiple sclerosis from exhaled breath using bilayers of polycyclic aromatic hydrocarbons and single-wall carbon nanotubes. ACS Chem Neurosci. 2011 Dec 21;2(12):687-93. doi: 10.1021/cn2000603. Epub 2011 Sep 22.

    PMID: 22860162BACKGROUND

  • Nakhleh MK, Amal H, Jeries R, Broza YY, Aboud M, Gharra A, Ivgi H, Khatib S, Badarneh S, Har-Shai L, Glass-Marmor L, Lejbkowicz I, Miller A, Badarny S, Winer R, Finberg J, Cohen-Kaminsky S, Perros F, Montani D, Girerd B, Garcia G, Simonneau G, Nakhoul F, Baram S, Salim R, Hakim M, Gruber M, Ronen O, Marshak T, Doweck I, Nativ O, Bahouth Z, Shi DY, Zhang W, Hua QL, Pan YY, Tao L, Liu H, Karban A, Koifman E, Rainis T, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Tolmanis I, Johnson D, Millstone SZ, Fulton J, Wells JW, Wilf LH, Humbert M, Leja M, Peled N, Haick H. Diagnosis and Classification of 17 Diseases from 1404 Subjects via Pattern Analysis of Exhaled Molecules. ACS Nano. 2017 Jan 24;11(1):112-125. doi: 10.1021/acsnano.6b04930. Epub 2016 Dec 21.

    PMID: 28000444BACKGROUND

  • Peng G, Tisch U, Adams O, Hakim M, Shehada N, Broza YY, Billan S, Abdah-Bortnyak R, Kuten A, Haick H. Diagnosing lung cancer in exhaled breath using gold nanoparticles. Nat Nanotechnol. 2009 Oct;4(10):669-73. doi: 10.1038/nnano.2009.235. Epub 2009 Aug 30.

    PMID: 19809459BACKGROUND

  • Gilgun-Sherki Y, Melamed E, Offen D. The role of oxidative stress in the pathogenesis of multiple sclerosis: the need for effective antioxidant therapy. J Neurol. 2004 Mar;251(3):261-8. doi: 10.1007/s00415-004-0348-9.

    PMID: 15015004BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ariel Miller

    Multiple Sclerosis Clinc, Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Multiple Sclerosis & Brain Research Center

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 30, 2019

Study Start

December 16, 2019

Primary Completion

May 23, 2022

Study Completion

August 2, 2022

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

IL(1)