Investigating genetic and molecular factors in multiple sclerosis outcomes
From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis
This study is trying to find out how genetic and molecular differences in people with multiple sclerosis can explain why some have a more severe form of the disease than others.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, Loire-Atlantique) |
| Trial ID | NCT04873492 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the genetic and transcriptomic differences in patients with multiple sclerosis (MS) to understand why some individuals experience aggressive disease progression while others do not. By analyzing biological samples from patients with clinical isolated syndrome, the research will focus on identifying differentially expressed molecules and cell subpopulations among aggressive and non-aggressive MS patients compared to healthy controls. The study will involve the collection of biological samples to facilitate these analyses, contributing to a better understanding of MS heterogeneity.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with clinical isolated syndrome, either aggressive or non-aggressive forms of multiple sclerosis.
Not a fit: Patients with a history of clinically isolated syndrome or multiple sclerosis who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved personalized treatment strategies for patients with multiple sclerosis.
How similar studies have performed: While similar studies have explored genetic factors in MS, this specific approach focusing on transcriptomics and aggressive versus non-aggressive outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : Common criteria for retrospective MS patients: * Patients aged 18 years or older * Clinical isolated syndrome (CIS) with or without dissemination in space * Patients affiliated to an appropriate health insurance Criteria for Aggressive MS group • Start of a 2nd line therapy within the two years following the CIS Criteria for Non aggressive MS group * No conversion according to McDonald criteria from clinical isolated syndrome to multiple sclerosis within 2 years or * Conversion based to McDonald criteria treated or not with first line disease modifying therapy within 2 years. * Have a minimum of least 2 years of follow-up. Healthy volunteers * Aged 18 years or older * No history of clinically isolated syndrome or MS Pairing criteria : * Age +/- 5 years * Sex Prospective MS Patients * Patients aged 18 years or older * Clinical isolated syndrome (CIS) with or without dissemination in space * Patients affiliated to an appropriate health insurance Exclusion Criteria : * Ongoing participation to a another study * Refusal to genetic analyses * Immunosuppressive drug at the time of blood collection * Plasma exchange or corticosteroid treatment within the four weeks prior to blood sample * Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard) * Pregnancy
Where this trial is running
Nantes, Loire-Atlantique
- Nantes University Hospital — Nantes, Loire-Atlantique, France (Recruiting)
Study contacts
- Study coordinator: David LAPLAUD, PhD
- Email: david.laplaud@chu-nantes.fr
- Phone: 33 2 40 16 52 00
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.