From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis
Unlocking the secrets of aggressive Multiple Sclerosis through genetic and molecular analysis.
Plain English Summary
From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis is a Not Applicable clinical trial sponsored by Nantes University Hospital studying Multiple Sclerosis. This study aims to understand why some people with Multiple Sclerosis (MS) experience a more severe form of the disease. It is for individuals diagnosed with a recent form of MS (Clinical Isolated Syndrome) and healthy volunteers. Participation involves providing blood samples for genetic and molecular analysis. Currently, there are no specific alternatives to participating in this research study. The trial aims to enroll 130 participants.
Official Summary
MS is a heterogeneous disease either in its response to treatment or clinical manifestation. Indeed, the natural history of MS is varying from a benign condition to a devastating and rapidly incapacitating disease. Clinical heterogeneity could also be cellular and / or molecular. The aim is to identify from OMIC analyses, at the early stage of the disease, differentially expressed molecules and / or cell subpopulations derived from CD8 + T lymphocytes and / or CD4 + T lymphocytes and / or B lymphocytes and monocytes from patients with aggressive versus non-aggressive, compared to a cohort of healthy controls
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have been diagnosed with Clinical Isolated Syndrome (CIS) recently. You cannot join if you are currently in another study, refuse genetic testing, are taking immunosuppressive drugs, or have recently had plasma exchange or corticosteroid treatment. Healthy volunteers aged 18 and older with no history of MS are also welcome. Pregnant individuals or those under legal protection are excluded. This trial is studying Multiple Sclerosis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures will help researchers understand the underlying genetic and molecular differences between aggressive and non-aggressive forms of MS, potentially leading to earlier diagnos The specific primary outcome measures are: Bulk RNA-sequencing (Blood sample collection within 6 months after first inflammatory event for MS patients and at inclusion for healthy volunteers.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it seeks to identify early markers of aggressive MS, which could lead to better personalized treatments and improved outcomes for patients. This research targets Multiple Sclerosis, where improved treatment options are needed.
Investor Insight
This trial focuses on understanding disease mechanisms, which could inform the development of new diagnostic tools or therapies for MS, a condition with a significant patient population and ongoing re
Is This Trial Right for Me?
Ask your doctor if your condition fits the criteria for aggressive or non-aggressive MS. Be prepared to provide blood samples; approximately 100 ml will be collected. You may be asked for optional saliva and stool samples. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 130 participants
Interventions
- OTHER: Biological sample collection — Venous blood sample will be collected from patients belonging to validation cohort and healthy volunteers at baseline resulting in 90 Ml EDTA tube and 10 ml serum tube. Approximately 100 ml will be collected. optional saliva and stool collection will be performed.
Primary Outcomes
- Bulk RNA-sequencing (Blood sample collection within 6 months after first inflammatory event for MS patients and at inclusion for healthy volunteers.)
Secondary Outcomes
- Single RNA sequencing (Blood sample collection within 6 months after first inflammatory event.)
- Association of genetic sequence variation from whole genome sequencing with gene expression profile via Bulk RNA-seq (Blood sample collection within 6 months after first inflammatory event.)
- Association of transcriptomic variation with DNA methylation (Blood sample collection within 6 months after first inflammatory event.)
- OMIC integration (Blood sample collection within 6 months after first inflammatory event.)
Full Eligibility 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
Trial Locations
- Nantes University Hospital, Nantes, Loire-Atlantique, France
Frequently Asked Questions
What is clinical trial NCT04873492?
NCT04873492 is a Not Applicable INTERVENTIONAL study titled "From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis." It is currently recruiting and is sponsored by Nantes University Hospital. The trial targets enrollment of 130 participants.
What conditions does NCT04873492 study?
This trial investigates treatments for Multiple Sclerosis. The primary condition under study is Multiple Sclerosis.
What treatments are being tested in NCT04873492?
The interventions being studied include: Biological sample collection (OTHER). Venous blood sample will be collected from patients belonging to validation cohort and healthy volunteers at baseline resulting in 90 Ml EDTA tube and 10 ml serum tube. Approximately 100 ml will be collected. optional saliva and stool collection will be performed.
What does Not Applicable mean for NCT04873492?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04873492?
This trial is currently "Recruiting." It started on 2022-01-24. The estimated completion date is 2029-07-24.
Who is sponsoring NCT04873492?
NCT04873492 is sponsored by Nantes University Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04873492?
The trial aims to enroll 130 participants. The trial is currently recruiting and accepting new participants.
How is NCT04873492 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT04873492?
The primary outcome measures are: Bulk RNA-sequencing (Blood sample collection within 6 months after first inflammatory event for MS patients and at inclusion for healthy volunteers.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04873492 being conducted?
This trial is being conducted at 1 site, including Nantes, Loire-Atlantique (France).
Where can I find official information about NCT04873492?
The official record for NCT04873492 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04873492. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04873492 testing in simple terms?
This study aims to understand why some people with Multiple Sclerosis (MS) experience a more severe form of the disease. It is for individuals diagnosed with a recent form of MS (Clinical Isolated Syndrome) and healthy volunteers.
Why is this trial significant?
This trial is important because it seeks to identify early markers of aggressive MS, which could lead to better personalized treatments and improved outcomes for patients.
What are the potential risks of participating in NCT04873492?
The main risk is discomfort or bruising from blood collection. Potential side effects are related to the blood draw itself, such as minor pain or swelling. There is a risk of incidental findings from genetic analysis, which will be discussed with participants. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04873492?
Ask your doctor if your condition fits the criteria for aggressive or non-aggressive MS. Be prepared to provide blood samples; approximately 100 ml will be collected. You may be asked for optional saliva and stool samples. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04873492 signal from an investment perspective?
This trial focuses on understanding disease mechanisms, which could inform the development of new diagnostic tools or therapies for MS, a condition with a significant patient population and ongoing re This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing blood samples for genetic and molecular analysis. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.