Multiple SclerosisOUTCOMSNCT04873492
From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis
A study testing Biological sample collection in people with Multiple Sclerosis, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Biological sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2022to 24 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
David LAPLAUD, Phd, 33240165200, david.laplaud@chu-nantes.fr
About this study
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
- Conditions
- Multiple Sclerosis
- Being tested
- Biological sample collection
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Aggressive MS patients | Other | Patients from who the clinical outcome is already known and classified as poor based on study definition detailed in inclusion criteria (retrospective arm). Blood sample collected after first event is available and used to characterize OMIC profile of T and B cells involve in MS. Receives: Other: Biological sample collection |
| Retrospective Non Aggressive MS patient | Other | Patient from who the clinical outcome is already known and classified as non-aggressive based on study definition detailed in inclusion criteria (retrospective arm). Blood sample collected after first event is available and used to characterize OMIC profile of T and B cells involve in MS. Receives: Other: Biological sample collection |
| Healthy volunteers | Other | Prospective arm use as comparator. Receives: Other: Biological sample collection |
| Prospective MS patients | Other | MS patients from who the clinical outcome will be established at the end of the follow up. Blood sample will be collected after the first event to validate molecules of interest from OMIC results by using FACS a different technology and classify MS patient. Receives: Other: Biological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bulk RNA-sequencing
Transcriptional profile of T and B cells in aggressive and non-aggressive MS and healthy volunteers. Measurement of gene expression of naïve and memory CD4+ and CD8+ T and B cell. Comparison of these expression level between MS patients with aggressive and non-aggressive form and healthy volunteers.
Measured: Blood sample collection within 6 months after first inflammatory event for MS patients and at inclusion for healthy volunteers.
Secondary outcomes (4)
Single RNA sequencing
Single cell transcriptomics of T and B cells in order to identify by clustering, sub populations within these cells based on gene expression and associated to poor pronostic.
Measured: 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
Add genetic variant analyzes to RNA seq analyses related to MS 1) Identify eQTL. 2 Impute SNPs result to calculate MS Genetic Burden (MSGB) a polygenic risk score of MS computed based on a weighted scoring algorithm using independent MS-SNPs.
Measured: Blood sample collection within 6 months after first inflammatory event.
Association of transcriptomic variation with DNA methylation
Add Analyzes of gene expression regulation throughout DNA methylation of CpG sites to RNA seq analyses related to MS.
Measured: Blood sample collection within 6 months after first inflammatory event.
OMIC integration
Developing machine learning method to combine genomic, epigenomic transcriptomic and clinical data to pinpoint genes of interest particularly involved in aggressive MS outcomes.
Measured: Blood sample collection within 6 months after first inflammatory event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start24 Jan 2022
- Primary completion24 Jul 2029 (estimated)
- Study completion24 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study model consists of two cohorts, the first one or "learning cohort" includes a group of health volunteers and 2 groups of MS patients from who clinical outcome (aggressive vs non-aggressive) is already known based on clinical follow up since first event. Clinical data and blood sample have been already collected and are available from OFSEP (Observatoire français de la Sclérose en plaques). Blood will be analyzed to characterize transcriptomic, epigenomic, genomic immune cells features to discover predictive markers of clinical outcome. The second cohort or "validation cohort" consists of MS patients enrolled after their first event and followed for maximum 2-years until the determination of their clinical outcome. Blood will be collected after their first event and used in FACS to classified the patients based on molecule of interest discover thanks to learning cohort and predict clinical outcome.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873492
- Sponsor's protocol ID
- RC20_0404
- Acronym
- OUTCOMS
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04873492
- Acronym / sponsor ID
- OUTCOMS / RC20_0404
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 24 Jul 2029 (estimated)
- Study completion
- 24 Jul 2029 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study model consists of two cohorts, the first one or "learning cohort" includes a group of health volunteers and 2 groups of MS patients from who clinical outcome (aggressive vs non-aggressive) is already known based on clinical follow up since first event. Clinical data and blood sample have been already collected and are available from OFSEP (Observatoire français de la Sclérose en plaques). Blood will be analyzed to characterize transcriptomic, epigenomic, genomic immune cells features to discover predictive markers of clinical outcome. The second cohort or "validation cohort" consists of MS patients enrolled after their first event and followed for maximum 2-years until the determination of their clinical outcome. Blood will be collected after their first event and used in FACS to classified the patients based on molecule of interest discover thanks to learning cohort and predict clinical outcome.
| Arm | Type | Receives |
|---|---|---|
| Retrospective Aggressive MS patients | Other | Other: Biological sample collectionPatients from who the clinical outcome is already known and classified as poor based on study definition detailed in inclusion criteria (retrospective arm). Blood sample collected after first event is available and used to characterize OMIC profile of T and B cells involve in MS. |
| Retrospective Non Aggressive MS patient | Other | Other: Biological sample collectionPatient from who the clinical outcome is already known and classified as non-aggressive based on study definition detailed in inclusion criteria (retrospective arm). Blood sample collected after first event is available and used to characterize OMIC profile of T and B cells involve in MS. |
| Healthy volunteers | Other | Other: Biological sample collectionProspective arm use as comparator. |
| Prospective MS patients | Other | Other: Biological sample collectionMS patients from who the clinical outcome will be established at the end of the follow up. Blood sample will be collected after the first event to validate molecules of interest from OMIC results by using FACS a different technology and classify MS patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collectionVenous 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. | Other | Healthy volunteers, Prospective MS patients, Retrospective Aggressive MS patients, Retrospective Non Aggressive MS patient |
Primary outcome
Bulk RNA-sequencing
Time frame: Blood sample collection within 6 months after first inflammatory event for MS patients and at inclusion for healthy volunteers.
Transcriptional profile of T and B cells in aggressive and non-aggressive MS and healthy volunteers. Measurement of gene expression of naïve and memory CD4+ and CD8+ T and B cell. Comparison of these expression level between MS patients with aggressive and non-aggressive form and healthy volunteers.
4 secondary outcomes
Single RNA sequencing
Time frame: 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
Time frame: Blood sample collection within 6 months after first inflammatory event.
Association of transcriptomic variation with DNA methylation
Time frame: Blood sample collection within 6 months after first inflammatory event.
OMIC integration
Time frame: Blood sample collection within 6 months after first inflammatory event.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sample collection in people with Multiple Sclerosis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David LAPLAUD, PhD (33 2 40 16 52 00, david.laplaud@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bulk RNA-sequencing (time frame: Blood sample collection within 6 months after first inflammatory event for MS patients and at inclusion for healthy volunteers.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.