Observing factors affecting multiple sclerosis progression
Very High Definition Cohort: Assessment of New Prognostic Biomarkers of Disability Worsening in a Multicenter Cohort of MS Patients by Imaging, Optical Coherence Tomography and Biology
This study looks at people with multiple sclerosis to see how different factors like age and gender affect how their condition gets worse over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EDMUS Foundation Academic / other |
| Locations | 5 sites (Lyon and 4 other locations) |
| Trial ID | NCT05622643 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with multiple sclerosis (MS) to identify prognostic factors that influence the progression of disability. By utilizing advanced imaging techniques such as MRI, the study aims to gather data on various factors, including age, gender, and the presence of lesions, to better understand how these elements contribute to individual patient outcomes. Participants must already be part of the OFSEP High Definition cohort and provide informed consent for inclusion. The study seeks to enhance predictive capabilities regarding disability progression in MS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients already enrolled in the OFSEP High Definition cohort who have provided informed consent.
Not a fit: Patients who have experienced a relapse in the previous 3 months or have contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of disability progression in MS patients, allowing for earlier and more tailored treatment interventions.
How similar studies have performed: Other studies have shown promise in identifying prognostic factors for MS progression, but this specific approach may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
For MS patients: * Inclusion Criteria: * The patient must be already included in the OFSEP High Definition cohort (NCT03603457). * The patient must have given his informed and signed consent for the inclusion in the VHD cohort. * The patient must be insured or beneficiary of a health insurance plan. * Exclusion Criteria: * 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: * Inclusion Criteria: * The healthy subject must be older than 18 years * The healthy subject must have given his informed and signed consent for the inclusion in the VHD cohort. * The healthy subject must be insured or beneficiary of a health insurance plan. * Exclusion Criteria: * 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). * The healthy subject has a history of disease that may affect the central nervous system. * The healthy subject has a family history of MS.
Where this trial is running
Lyon and 4 other locations
- 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)
Study contacts
- Study coordinator: Anne Kerbrat, Dr
- Email: anne.kerbrat@chu-rennes.fr
- Phone: +33 (0)2 99 28 43 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.