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出境医 / 临床实验 / Serum Neurofilament-light Chain Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis (NeurofilMS)
Serum Neurofilament-light Chain Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis (NeurofilMS)
Study Description
Brief Summary:
The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.
| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Sclerosis | Diagnostic Test: Blood sample |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1750 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Serum Neurofilament-light Chain Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis |
| Actual Study Start Date : | May 22, 2019 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| MS Patients |
Diagnostic Test: Blood sample
2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain levels
|
Outcome Measures
Primary Outcome Measures :
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [ Time Frame: 12 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
Secondary Outcome Measures :
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients. [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients. [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients. [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients. [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients. [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapse compared to stable patients [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapse compared to stable patients [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapse compared to stable patients [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapse compared to stable patients [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapse compared to stable patients [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients [ Time Frame: 2 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity) [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity) [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity) [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity) [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity) [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity) [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse, or MRI activity) [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity) [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity) [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity) [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapses [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapses [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapses [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapses [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with relapses [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with MRI activity [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with MRI activity [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with MRI activity [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with MRI activity [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with MRI activity [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement [ Time Frame: 6 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement [ Time Frame: 1 year ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement [ Time Frame: 18 months ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement [ Time Frame: 2 years ]pg/mL; measured by digital ELISA
- Level of disability [ Time Frame: Inclusion ]Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis
- Level of disability [ Time Frame: Relapse (measured up to 2 years) ]Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis
- Severity of multiple sclerosis [ Time Frame: EDSS progression (measured up to 2 years) ]Multiple Sclerosis Functional Composite
- Severity of multiple sclerosis [ Time Frame: Active MRI (measured up to 2 years) ]Multiple Sclerosis Functional Composite
- Generic health status [ Time Frame: Inclusion ]EuroQol 5 dimension questionnaire (EQ-5D)
- Generic health status [ Time Frame: Relapse (measured up to 2 years) ]EuroQol 5 dimension questionnaire (EQ-5D)
- Generic health status [ Time Frame: EDSS progression (measured up to 2 years) ]EuroQol 5 dimension questionnaire (EQ-5D)
- Generic health status [ Time Frame: active MRI (measured up to 2 years) ]EuroQol 5 dimension questionnaire (EQ-5D)
- Use of Disease Modifying Drugs [ Time Frame: Inclusion ]Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
- Use of Disease Modifying Drugs [ Time Frame: 6 monrths ]Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
- Use of Disease Modifying Drugs [ Time Frame: 1 year ]Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
- Use of Disease Modifying Drugs [ Time Frame: 18 months ]Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
- Use of Disease Modifying Drugs [ Time Frame: 2 years ]Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
- Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients [ Time Frame: Month 6 ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion [ Time Frame: Inclusion ]pg/mL; measured by digital ELISA
- Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion [ Time Frame: Month 6 ]pg/mL; measured by digital ELISA
- Create biobank [ Time Frame: Inclusion ]Blood samples
- Create biobank [ Time Frame: 6 months ]Blood samples
- Create biobank [ Time Frame: 1 year ]Blood samples
- Create biobank [ Time Frame: 18 months ]Blood samples
- Create biobank [ Time Frame: 2 years ]Blood samples
Biospecimen Retention: Samples With DNA
Blood samples
Eligibility Criteria
| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The study population is composed of consecutive patients over 15 years of age, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of 30 OFSEP centres and of Nîmes and Nantes University Hospitals. The patients recruited will have an EDSS score comprised between 0 - 7.0.
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 (≥)15 years old.
-
The patient has MS according to diagnosis criteria (Thompson et al. 2017) and:
- Participates to the OFSEP-HD cohort (ancillary study);
- Has a Expanded Disability Status Scale score comprised between 0 - 7.0;
- With or without Disease Modifying Drug;
- For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmark criteria for an active MS (relapse, or Expanded Disability Status Scale progression, or active MRI) during follow-up;
- For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in Nîmes or Nantes University Hospitals.
Exclusion Criteria:
- Within the past three months, the patient has participated in another interventional study that may interfere with the results or conclusions of this study.
- 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.
- The patient is under 15 years old.
- Inability to answer questionnaires.
- Clinically isolated syndrome (CIS) that does not meet the criteria of MS.
- Radiologically isolated syndrome (RIS).
- Patient with Neuromyelitis optica spectrum disorder.
Contacts and Locations
Contacts
| Contact: Eric Thouvenot | +33.(0)4.66.68.32.61 | eric.thouvenot@chu-nimes.fr |
Locations
Show 28 study locations
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Eric Thouvenot | CHU Nimes |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 23, 2019 | ||||
| First Posted Date | June 10, 2019 | ||||
| Last Update Posted Date | August 13, 2020 | ||||
| Actual Study Start Date | May 22, 2019 | ||||
| Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Serum Neurofilament-light Chain Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis | ||||
| Official Title | Serum Neurofilament-light Chain Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis | ||||
| Brief Summary | The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description:
Blood samples
|
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The study population is composed of consecutive patients over 15 years of age, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of 30 OFSEP centres and of Nîmes and Nantes University Hospitals. The patients recruited will have an EDSS score comprised between 0 - 7.0. | ||||
| Condition | Multiple Sclerosis | ||||
| Intervention | Diagnostic Test: Blood sample
2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain levels
|
||||
| Study Groups/Cohorts | MS Patients
Intervention: Diagnostic Test: Blood sample
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
1750 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 2023 | ||||
| Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 15 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
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| Listed Location Countries | France, Martinique | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03981003 | ||||
| Other Study ID Numbers | CIVI/2018/ET-02 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Centre Hospitalier Universitaire de Nīmes | ||||
| Study Sponsor | Centre Hospitalier Universitaire de Nīmes | ||||
| Collaborators | Hospices Civils de Lyon | ||||
| Investigators |
|
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| PRS Account | Centre Hospitalier Universitaire de Nīmes | ||||
| Verification Date | August 2020 | ||||
