OFSEP Very High Definition Cohort

NCT05622643 | Recruiting

• 1 other identifier: 004
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

Brief Summary

Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Early use of disease modifying treatments for patients at risk of developing disability is therefore essential. However, disability progression is very heterogeneous between patients and currently impossible to predict at the individual level. Thus, numerous studies, particularly epidemiological and imaging studies, have identified prognostic factors for the development of disability such as age, gender, number of relapses during the first years of the disease, existence of a residual disability after a first relapse, number of gadolinium-enhancing lesions on initial MRI, early brainstem and spinal cord lesions. However, these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients. In particular, some components of MS pathophysiology, more related to the progressive development of disability, such as axonal degeneration or the existence of chronic inflammation of the central nervous system (CNS) are usually not measured by these biomarkers. In this research project, the investigators will test promising biomarkers, focused on these components of the disease, on a large cohort of patients in a multicenter setting, in order to evaluate their added value to predict disability progression, in comparison with more classical biomarkers such as clinical characteristics, and brain and spinal cord lesion load. In particular, the investigators will test:

• Imaging biomarkers extracted from brain and spinal cord MP2RAGE, brain and spinal cord QSM, brain and spinal cord relaxometry, brain diffusion and spinal cord magnetization transfer sequences
• Biomarkers extracted from optical coherence tomography (OCT)
• Biological biomarkers (serum neurofilament-light chain (NFL) and Glial Fibrillary Acidic Protein (GFAP))

Conditions

Multiple Sclerosis

Keywords

Prognostic factors; MS progression; MRI; OCT; NFL; GFAP

Outcome Measures

Primary Outcomes (1)

• Global disability progression

  Global disability progression will be scored by the Expanded disability score system (EDSS). Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was

  2 years

Secondary Outcomes (9)

• Composite disability progression score

  2 years

• Change in the Symbol Digit Modalities Test score

  2 years

• Change in the American Spinal Cord Injury Association motor sub-score

  2 years

• Focal inflammatory activity

  2 years

• No evidence of disease activity 3

  2 years

Study Arms (2)

Patients with MS

250 patients with MRI, OCT and bio sample

Other: MRI

Healthy subjects

50 healthy subjects with MRI

Other: MRI

Interventions

MRI OTHER

Comparison between groups

Healthy subjects; Patients with MS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In order to ensure the inclusion of patients with different MS phenotypes representative of the general MS patients population in the VHD cohort, the investigators will aim to respect the inclusion percentages of at least 10% of patients with primary progressive MS and at least 15% of patients with secondary progressive MS.

You may qualify if:

• The patient must be already included in the OFSEP High Definition cohort (NCT03603457).
• The patient must be insured or beneficiary of a health insurance plan.

You may not qualify if:

• 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 has experienced a relapse in the previous 3 months.
• The patient is pregnant or breast-feeding (MRI contraindicated).
• Patient with MRI contra-indications (patient with a pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implants or in whom there is a suspicion of a metallic foreign body).
• The patient has a severe psychiatric illness
• The patient has severe chronic alcoholism
• For healthy subjects:
• The healthy subject must be older than 18 years
• The healthy subject must be insured or beneficiary of a health insurance plan.
• The healthy subject is under judicial protection.
• It is impossible to correctly inform the healthy subject (Inability to understand the study, language problem).
• The healthy subject is pregnant or breast-feeding (MRI contraindicated).
• The healthy subject has MRI contra-indications (a pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implants or in whom there is a suspicion of a metallic foreign body).

Sponsors & Collaborators

• EDMUS Foundation: lead

Study Sites (5)

CHU de Lyon

Lyon, France

NOT YET RECRUITING

CHU de Nancy

Nancy, France

NOT YET RECRUITING

CHU de Nîmes

Nîmes, France

NOT YET RECRUITING

CHU de Rennes

Rennes, France

RECRUITING

CHU de Strasbourg

Strasbourg, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Anne Kerbrat, Dr

CONTACT

+33 (0)2 99 28 43 21; anne.kerbrat@chu-rennes.fr

Eric Thouvenot, Pr.

CONTACT

eric.thouvenot@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: November 18, 2022
• Study Start: January 19, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (5)