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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03152-53 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Institut de Recherches en Biothérapie | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain MRI | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum Neurofilament Light Chain serum levels since baseline | pg/mL; measured by digital ELISA | Baseline; 1 year |
| Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline | pg/mL; measured by digital ELISA | Baseline; 1 year |
| Change in Ganglion Cell Complex thickness since baseline | Measured by Optical Coherence Tomography | Baseline; 1 year |
| Change in whole brain volume since baseline | Assessed by MRI | Baseline; 1 year |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | Baseline |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Whole brain volume | assessed by MRI | Inclusion |
| Whole brain volume | assessed by MRI | 6 Months |
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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:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Thouvenot | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nimes | Nîmes | 30029 | France |
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Blood samples
| Spinal Cord MRI | Diagnostic Test | Sagittal T2 Sagittal T1 with Gadolinium injection |
|
| Retinal imaging | Diagnostic Test | spectral-domain high definition optical coherence tomography |
|
| Whole brain volume | assessed by MRI | 1 Year |
| Whole brain volume | assessed by MRI | 2 years |
| Whole brain volume | assessed by MRI | 3 Years |
| Whole brain volume | assessed by MRI | 4 Years |
| Whole brain volume | assessed by MRI | 5 years |
| Whole brain volume | assessed by MRI | any relapse (max 5 years) |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | Inclusion |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 6 Months |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 1 year |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 18 months |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 2 years |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 2.5 years |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 3 years |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 3.5 years |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 4 years |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 4.5 years |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | 5 years |
| Expanded Disability Status Scale | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) | Any relapse (Maximum 5 years) |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | Inclusion |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | 6 Months |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | 1 Year |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | 18 Months |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | 2 years |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | 3 Years |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | 4 Years |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | 5 Years |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | assessed by Optical Coherence Tomography | Any relapse (maximum 5 Years) |
| Gadolinium-enhanced lesions | assessed by MRI | Inclusion |
| Gadolinium-enhanced lesions | assessed by MRI | 6 Months |
| Gadolinium-enhanced lesions | assessed by MRI | 1 Year |
| Gadolinium-enhanced lesions | assessed by MRI | 2 years |
| Gadolinium-enhanced lesions | assessed by MRI | 3 Years |
| Gadolinium-enhanced lesions | assessed by MRI | 4 Years |
| Gadolinium-enhanced lesions | assessed by MRI | 5 Years |
| Gadolinium-enhanced lesions | assessed by MRI | Any relapse (Maximum 5 Years) |
| T2 lesion volume, | assessed by MRI | Inclusion |
| T2 lesion volume, | assessed by MRI | 6 Months |
| T2 lesion volume, | assessed by MRI | 1 Year |
| T2 lesion volume, | assessed by MRI | 2 years |
| T2 lesion volume, | assessed by MRI | 3 Years |
| T2 lesion volume, | assessed by MRI | 4 Years |
| T2 lesion volume, | assessed by MRI | 5 years |
| T2 lesion volume, | assessed by MRI | Any relapse (maximum 5 years) |
| Grey matter atrophy | assessed by MRI | Inclusion |
| Grey matter atrophy | assessed by MRI | 6 Months |
| Grey matter atrophy | assessed by MRI | 1 Year |
| Grey matter atrophy | assessed by MRI | 2 years |
| Grey matter atrophy | assessed by MRI | 3 Years |
| Grey matter atrophy | assessed by MRI | 4 Years |
| Grey matter atrophy | assessed by MRI | 5 Years |
| Grey matter atrophy | assessed by MRI | Any relapse (maximum 5 Years) |
| White matter atrophy | assessed by MRI | Inclusion |
| White matter atrophy | assessed by MRI | 6 Months |
| White matter atrophy | assessed by MRI | 1 Year |
| White matter atrophy | assessed by MRI | 2 years |
| White matter atrophy | assessed by MRI | 3 Years |
| White matter atrophy | assessed by MRI | 4 Years |
| White matter atrophy | assessed by MRI | 5 years |
| White matter atrophy | assessed by MRI | Any relapse (maximum 5 years) |
| Thalamic atrophy | assessed by MRI | Inclusion |
| Thalamic atrophy | assessed by MRI | 6 Months |
| Thalamic atrophy | assessed by MRI | 1 Year |
| Thalamic atrophy | assessed by MRI | 2 years |
| Thalamic atrophy | assessed by MRI | 3 Years |
| Thalamic atrophy | assessed by MRI | 4 Years |
| Thalamic atrophy | assessed by MRI | 5 years |
| Thalamic atrophy | assessed by MRI | Any relapse (maximum 5 years) |
| Disease modifying drugs classification | Drug class (1st, 2nd or 3rd line) | Inclusion |
| Disease modifying drugs classification | Drug class (1st, 2nd or 3rd line) | until end of study (5 years) |
| serum NfL levels | pg/mL; measured by digital ELISA | 6 Months |
| serum GFAP levels | pg/mL; measured by digital ELISA | 6 Months |
| serum NfL levels | pg/mL; measured by digital ELISA | 2 years |
| serum GFAP levels | pg/mL; measured by digital ELISA | 2 years |
| serum NfL levels | pg/mL; measured by digital ELISA | 3 years |
| serum GFAP levels | pg/mL; measured by digital ELISA | 3 years |
| serum NfL levels | pg/mL; measured by digital ELISA | 4 years |
| serum GFAP levels | pg/mL; measured by digital ELISA | 4 years |
| serum NfL levels | pg/mL; measured by digital ELISA | 5 years |
| serum GFAP levels | pg/mL; measured by digital ELISA | 5 years |
| serum NfL levels | pg/mL; measured by digital ELISA | Any relapse (maximum 5 years) |
| serum GFAP levels | pg/mL; measured by digital ELISA | Any relapse (maximum 5 years) |
| Multiple Sclerosis Functional Composite | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) | Inclusion |
| Multiple Sclerosis Functional Composite | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) | 6 Months |
| Multiple Sclerosis Functional Composite | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) | 1 Year |
| Multiple Sclerosis Functional Composite | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) | 2 years |
| Multiple Sclerosis Functional Composite | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) | 3 years |
| Multiple Sclerosis Functional Composite | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) | 4 years |
| Multiple Sclerosis Functional Composite | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) | 5 years |
| Multiple Sclerosis Functional Composite | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) | Any relapse (maximum 5 years) |
| Time to walk 100 meters | Seconds | Inclusion |
| Time to walk 100 meters | Seconds | 6 Months |
| Time to walk 100 meters | Seconds | 1 Year |
| Time to walk 100 meters | Seconds | 2 years |
| Time to walk 100 meters | Seconds | 3 years |
| Time to walk 100 meters | Seconds | 4 years |
| Time to walk 100 meters | Seconds | 5 years |
| Time to walk 100 meters | Seconds | Any relapse (maximum 5 years) |
| 2 Minute walking distance | Meters | Inclusion |
| 2 Minute walking distance | Meters | 6 Months |
| 2 Minute walking distance | Meters | 1 Year |
| 2 Minute walking distance | Meters | 2 years |
| 2 Minute walking distance | Meters | 3 years |
| 2 Minute walking distance | Meters | 4 years |
| 2 Minute walking distance | Meters | 5 years |
| 2 Minute walking distance | Meters | Any relapse (maximum 5 years) |
| Cognitive Impairment | Symbol Digit Modalities Test | Inclusion |
| Cognitive Impairment | Symbol Digit Modalities Test | 6 months |
| Cognitive Impairment | Symbol Digit Modalities Test | 1 Year |
| Cognitive Impairment | Symbol Digit Modalities Test | 2 years |
| Cognitive Impairment | Symbol Digit Modalities Test | 3 years |
| Cognitive Impairment | Symbol Digit Modalities Test | 4 years |
| Cognitive Impairment | Symbol Digit Modalities Test | 5 years |
| Cognitive Impairment | Symbol Digit Modalities Test | Any relapse (maximum 5 years) |
| Cognitive evaluation | Brief International Cognitive Assessment for Multiple Sclerosis | Inclusion |
| Cognitive evaluation | Brief International Cognitive Assessment for Multiple Sclerosis | 6 Months |
| Cognitive evaluation | Brief International Cognitive Assessment for Multiple Sclerosis | 1 Year |
| Cognitive evaluation | Brief International Cognitive Assessment for Multiple Sclerosis | 2 years |
| Cognitive evaluation | Brief International Cognitive Assessment for Multiple Sclerosis | 3 years |
| Cognitive evaluation | Brief International Cognitive Assessment for Multiple Sclerosis | 4 years |
| Cognitive evaluation | Brief International Cognitive Assessment for Multiple Sclerosis | 5 years |
| Cognitive evaluation | Brief International Cognitive Assessment for Multiple Sclerosis | Any relapse (maximum 5 years) |
| Health-related quality of life | EQ-5D-5L | Inclusion |
| Health-related quality of life | EQ-5D-5L | 6 Months |
| Health-related quality of life | EQ-5D-5L | 1 Year |
| Health-related quality of life | EQ-5D-5L | 2 years |
| Health-related quality of life | EQ-5D-5L | 3 years |
| Health-related quality of life | EQ-5D-5L | 4 years |
| Health-related quality of life | EQ-5D-5L | 5 years |
| Health-related quality of life | EQ-5D-5L | Any relapse (maximum 5 years) |
| Impact of MS on daily life | Multiple Sclerosis Impact Scale (MSIS-29) | Inclusion |
| Impact of MS on daily life | Multiple Sclerosis Impact Scale (MSIS-29) | 6 Months |
| Impact of MS on daily life | Multiple Sclerosis Impact Scale (MSIS-29) | 1 Year |
| Impact of MS on daily life | Multiple Sclerosis Impact Scale (MSIS-29) | 2 years |
| Impact of MS on daily life | Multiple Sclerosis Impact Scale (MSIS-29) | 3 years |
| Impact of MS on daily life | Multiple Sclerosis Impact Scale (MSIS-29) | 4 years |
| Impact of MS on daily life | Multiple Sclerosis Impact Scale (MSIS-29) | 5 years |
| Impact of MS on daily life | Multiple Sclerosis Impact Scale (MSIS-29) | Any relapse (maximum 5 years) |
| Fatigue | Modified Fatigue Impact Scale | Inclusion |
| Fatigue | Modified Fatigue Impact Scale | 6 Months |
| Fatigue | Modified Fatigue Impact Scale | 1 Year |
| Fatigue | Modified Fatigue Impact Scale | 2 years |
| Fatigue | Modified Fatigue Impact Scale | 3 years |
| Fatigue | Modified Fatigue Impact Scale | 4 years |
| Fatigue | Modified Fatigue Impact Scale | 5 years |
| Fatigue | Modified Fatigue Impact Scale | Any relapse (maximum 5 years) |
| Visual acuity | 0= low, 10= good | Inclusion |
| Visual acuity | 0= low, 10= good | 6 Months |
| Visual acuity | 0= low, 10= good | 1 Year |
| Visual acuity | 0= low, 10= good | 2 years |
| Visual acuity | 0= low, 10= good | 3 years |
| Visual acuity | 0= low, 10= good | 4 years |
| Visual acuity | 0= low, 10= good | 5 years |
| Visual acuity | 0= low, 10 good | Any relapse (maximum 5 years) |
| Low contrast visual acuity | 0= low, 10 good | Inclusion |
| Low contrast visual acuity | 0= low, 10 good | 6 Months |
| Low contrast visual acuity | 0= low, 10 good | 1 Year |
| Low contrast visual acuity | 0= low, 10 good | 2 years |
| Low contrast visual acuity | 0= low, 10 good | 3 years, |
| Low contrast visual acuity | 0= low, 10 good | 4 years |
| Low contrast visual acuity | 0= low, 10 good | 5 years |
| Low contrast visual acuity | 0= low, 10 good | Any relapse (maximum 5 years) |
| Relapse description | monofocal, plurifocal | At relapse (maximum 5 years) |
| Number of new lesions | Measured by MRI | At relapse (maximum 5 years) |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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