Clinical trial NCT04860947: Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
Official title: Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Keywords: GFAP
NfL
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Institut de Recherches en Biothérapie
First posted: 2021-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of consecutive adult patients, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of Nîmes University Hospital (CHU). The patients recruited will have an EDSS score comprised between 0 - 7.0.

Brief summary: The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. baseline to predict later evolution of neurological disability in multiple sclerosis patients.


Eligibility criteria: Inclusion Criteria:

* The patient has been correctly informed.
* The patient must have given their informed and signed consent.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least (≥)18 years old.
* The patient has experienced a CIS, has currently a RRMS or progressive MS with:

  * Less than 10 years of disease duration;
  * With or without DMD;
  * EDSS score 0 - 7.0.

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study.
* The patient is under judicial protection.
* The patient refuses to sign the consent.
* It is impossible to correctly inform the patient (Inability to understand the study, language problem).
* The patient is pregnant or breast-feeding.
* Patient has a bilateral optic neuritis or other significant ophthalmological antecedent.
* Patient with MRI contra-indications.
* patient has a contraindication to gadolinium injection
* The patient has bilateral optic neuritis or other significant ophthalmological antecedent
* Patient is having a relapse or has had a relapse in the last 3 months
* The patient has a severe psychiatric illness
* The patient has severe chronic alcoholism

Primary outcomes:
measure: Change in serum Neurofilament Light Chain serum levels since baseline
timeFrame: Baseline; 1 year
measure: Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline
timeFrame: Baseline; 1 year
measure: Change in Ganglion Cell Complex thickness since baseline
timeFrame: Baseline; 1 year
measure: Change in whole brain volume since baseline
timeFrame: Baseline; 1 year
measure: Expanded Disability Status Scale
timeFrame: Baseline
measure: Expanded Disability Status Scale
timeFrame: 3 years
Secondary outcomes:
measure: Whole brain volume
timeFrame: Inclusion
measure: Whole brain volume
timeFrame: 6 Months
measure: Whole brain volume
timeFrame: 1 Year
measure: Whole brain volume
timeFrame: 2 years
measure: Whole brain volume
timeFrame: 3 Years
measure: Whole brain volume
timeFrame: 4 Years
measure: Whole brain volume
timeFrame: 5 years
measure: Whole brain volume
timeFrame: any relapse (max 5 years)
measure: Expanded Disability Status Scale
timeFrame: Inclusion
measure: Expanded Disability Status Scale
timeFrame: 6 Months
measure: Expanded Disability Status Scale
timeFrame: 1 year
measure: Expanded Disability Status Scale
timeFrame: 18 months
measure: Expanded Disability Status Scale
timeFrame: 2 years
measure: Expanded Disability Status Scale
timeFrame: 2.5 years
measure: Expanded Disability Status Scale
timeFrame: 3 years
measure: Expanded Disability Status Scale
timeFrame: 3.5 years
measure: Expanded Disability Status Scale
timeFrame: 4 years
measure: Expanded Disability Status Scale
timeFrame: 4.5 years
measure: Expanded Disability Status Scale
timeFrame: 5 years
measure: Expanded Disability Status Scale
timeFrame: Any relapse (Maximum 5 years)
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: Inclusion
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: 6 Months
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: 1 Year
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: 18 Months
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: 2 years
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: 3 Years
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: 4 Years
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: 5 Years
measure: Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
timeFrame: Any relapse (maximum 5 Years)
measure: Gadolinium-enhanced lesions
timeFrame: Inclusion
measure: Gadolinium-enhanced lesions
timeFrame: 6 Months
measure: Gadolinium-enhanced lesions
timeFrame: 1 Year
measure: Gadolinium-enhanced lesions
timeFrame: 2 years
measure: Gadolinium-enhanced lesions
timeFrame: 3 Years
measure: Gadolinium-enhanced lesions
timeFrame: 4 Years
measure: Gadolinium-enhanced lesions
timeFrame: 5 Years
measure: Gadolinium-enhanced lesions
timeFrame: Any relapse (Maximum 5 Years)
measure: T2 lesion volume,
timeFrame: Inclusion
measure: T2 lesion volume,
timeFrame: 6 Months
measure: T2 lesion volume,
timeFrame: 1 Year
measure: T2 lesion volume,
timeFrame: 2 years
measure: T2 lesion volume,
timeFrame: 3 Years
measure: T2 lesion volume,
timeFrame: 4 Years
measure: T2 lesion volume,
timeFrame: 5 years
measure: T2 lesion volume,
timeFrame: Any relapse (maximum 5 years)
measure: Grey matter atrophy
timeFrame: Inclusion
measure: Grey matter atrophy
timeFrame: 6 Months
measure: Grey matter atrophy
timeFrame: 1 Year
measure: Grey matter atrophy
timeFrame: 2 years
measure: Grey matter atrophy
timeFrame: 3 Years
measure: Grey matter atrophy
timeFrame: 4 Years
measure: Grey matter atrophy
timeFrame: 5 Years
measure: Grey matter atrophy
timeFrame: Any relapse (maximum 5 Years)
measure: White matter atrophy
timeFrame: Inclusion
measure: White matter atrophy
timeFrame: 6 Months
measure: White matter atrophy
timeFrame: 1 Year
measure: White matter atrophy
timeFrame: 2 years
measure: White matter atrophy
timeFrame: 3 Years
measure: White matter atrophy
timeFrame: 4 Years
measure: White matter atrophy
timeFrame: 5 years
measure: White matter atrophy
timeFrame: Any relapse (maximum 5 years)
measure: Thalamic atrophy
timeFrame: Inclusion
measure: Thalamic atrophy
timeFrame: 6 Months
measure: Thalamic atrophy
timeFrame: 1 Year
measure: Thalamic atrophy
timeFrame: 2 years
measure: Thalamic atrophy
timeFrame: 3 Years
measure: Thalamic atrophy
timeFrame: 4 Years
measure: Thalamic atrophy
timeFrame: 5 years
measure: Thalamic atrophy
timeFrame: Any relapse (maximum 5 years)
measure: Disease modifying drugs classification
timeFrame: Inclusion
measure: Disease modifying drugs classification
timeFrame: until end of study (5 years)
measure: serum NfL levels
timeFrame: 6 Months
measure: serum GFAP levels
timeFrame: 6 Months
measure: serum NfL levels
timeFrame: 2 years
measure: serum GFAP levels
timeFrame: 2 years
measure: serum NfL levels
timeFrame: 3 years
measure: serum GFAP levels
timeFrame: 3 years
measure: serum NfL levels
timeFrame: 4 years
measure: serum GFAP levels
timeFrame: 4 years
measure: serum NfL levels
timeFrame: 5 years
measure: serum GFAP levels
timeFrame: 5 years
measure: serum NfL levels
timeFrame: Any relapse (maximum 5 years)
measure: serum GFAP levels
timeFrame: Any relapse (maximum 5 years)
measure: Multiple Sclerosis Functional Composite
timeFrame: Inclusion
measure: Multiple Sclerosis Functional Composite
timeFrame: 6 Months
measure: Multiple Sclerosis Functional Composite
timeFrame: 1 Year
measure: Multiple Sclerosis Functional Composite
timeFrame: 2 years
measure: Multiple Sclerosis Functional Composite
timeFrame: 3 years
measure: Multiple Sclerosis Functional Composite
timeFrame: 4 years
measure: Multiple Sclerosis Functional Composite
timeFrame: 5 years
measure: Multiple Sclerosis Functional Composite
timeFrame: Any relapse (maximum 5 years)
measure: Time to walk 100 meters
timeFrame: Inclusion
measure: Time to walk 100 meters
timeFrame: 6 Months
measure: Time to walk 100 meters
timeFrame: 1 Year
measure: Time to walk 100 meters
timeFrame: 2 years
measure: Time to walk 100 meters
timeFrame: 3 years
measure: Time to walk 100 meters
timeFrame: 4 years
measure: Time to walk 100 meters
timeFrame: 5 years
measure: Time to walk 100 meters
timeFrame: Any relapse (maximum 5 years)
measure: 2 Minute walking distance
timeFrame: Inclusion
measure: 2 Minute walking distance
timeFrame: 6 Months
measure: 2 Minute walking distance
timeFrame: 1 Year
measure: 2 Minute walking distance
timeFrame: 2 years
measure: 2 Minute walking distance
timeFrame: 3 years
measure: 2 Minute walking distance
timeFrame: 4 years
measure: 2 Minute walking distance
timeFrame: 5 years
measure: 2 Minute walking distance
timeFrame: Any relapse (maximum 5 years)
measure: Cognitive Impairment
timeFrame: Inclusion
measure: Cognitive Impairment
timeFrame: 6 months
measure: Cognitive Impairment
timeFrame: 1 Year
measure: Cognitive Impairment
timeFrame: 2 years
measure: Cognitive Impairment
timeFrame: 3 years
measure: Cognitive Impairment
timeFrame: 4 years
measure: Cognitive Impairment
timeFrame: 5 years
measure: Cognitive Impairment
timeFrame: Any relapse (maximum 5 years)
measure: Cognitive evaluation
timeFrame: Inclusion
measure: Cognitive evaluation
timeFrame: 6 Months
measure: Cognitive evaluation
timeFrame: 1 Year
measure: Cognitive evaluation
timeFrame: 2 years
measure: Cognitive evaluation
timeFrame: 3 years
measure: Cognitive evaluation
timeFrame: 4 years
measure: Cognitive evaluation
timeFrame: 5 years
measure: Cognitive evaluation
timeFrame: Any relapse (maximum 5 years)
measure: Health-related quality of life
timeFrame: Inclusion
measure: Health-related quality of life
timeFrame: 6 Months
measure: Health-related quality of life
timeFrame: 1 Year
measure: Health-related quality of life
timeFrame: 2 years
measure: Health-related quality of life
timeFrame: 3 years
measure: Health-related quality of life
timeFrame: 4 years
measure: Health-related quality of life
timeFrame: 5 years
measure: Health-related quality of life
timeFrame: Any relapse (maximum 5 years)
measure: Impact of MS on daily life
timeFrame: Inclusion
measure: Impact of MS on daily life
timeFrame: 6 Months
measure: Impact of MS on daily life
timeFrame: 1 Year
measure: Impact of MS on daily life
timeFrame: 2 years
measure: Impact of MS on daily life
timeFrame: 3 years
measure: Impact of MS on daily life
timeFrame: 4 years
measure: Impact of MS on daily life
timeFrame: 5 years
measure: Impact of MS on daily life
timeFrame: Any relapse (maximum 5 years)
measure: Fatigue
timeFrame: Inclusion
measure: Fatigue
timeFrame: 6 Months
measure: Fatigue
timeFrame: 1 Year
measure: Fatigue
timeFrame: 2 years
measure: Fatigue
timeFrame: 3 years
measure: Fatigue
timeFrame: 4 years
measure: Fatigue
timeFrame: 5 years
measure: Fatigue
timeFrame: Any relapse (maximum 5 years)
measure: Visual acuity
timeFrame: Inclusion
measure: Visual acuity
timeFrame: 6 Months
measure: Visual acuity
timeFrame: 1 Year
measure: Visual acuity
timeFrame: 2 years
measure: Visual acuity
timeFrame: 3 years
measure: Visual acuity
timeFrame: 4 years
measure: Visual acuity
timeFrame: 5 years
measure: Visual acuity
timeFrame: Any relapse (maximum 5 years)
measure: Low contrast visual acuity
timeFrame: Inclusion
measure: Low contrast visual acuity
timeFrame: 6 Months
measure: Low contrast visual acuity
timeFrame: 1 Year
measure: Low contrast visual acuity
timeFrame: 2 years
measure: Low contrast visual acuity
timeFrame: 3 years,
measure: Low contrast visual acuity
timeFrame: 4 years
measure: Low contrast visual acuity
timeFrame: 5 years
measure: Low contrast visual acuity
timeFrame: Any relapse (maximum 5 years)
measure: Relapse description
timeFrame: At relapse (maximum 5 years)
measure: Number of new lesions
timeFrame: At relapse (maximum 5 years)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Eric Thouvenot
role: PRINCIPAL_INVESTIGATOR
References: