Multiple SclerosisRelSEPNCT02883335
Lorraine Registry of Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Observational registry
- How many people
- 6,000 participants
- Where
- 1 siteFrance
- Study dates
- May 2003to Jan 2030
- How long will I take part?
- 30 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from multiple sclerosis in Lorraine
Who may be able to join
- Having a confirmed multiple sclerosis diagnosis
- Living in Lorraine (French region)
Who cannot join
- Refusal to be registered
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francis Guillemin, MD, PHD contact
Jonathan Epstein, MD, MSc contact
France1 site, 1 recruiting
- Recruiting
CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy
Nancy, 54000
Jonathan Epstein, MD, MSc, j.epstein@chru-nancy.fr
About this study
The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events.
Read the detailed description
As every patient registry in France, the RelSEP is periodically (every four years) evaluated by an independent committee.
The RelSEP interrogate multiple sources to insure its exhaustiveness :
- every neurologists of Lorraine
- MS patient network in Lorraine
- health insurance data
- PMSI (administrative French national database for hospitals)
- biological and imagery services in Lorraine Procedures (automatic and manual) are used to eliminate duplicates Once a patient has been identified its medical file are checked by investigators in order to retrieve the relevant information.
New MS cases are confirmed by neurologists. Automatics (implemented in EDMUS software)and manual checks are implemented in the registry database, looking for inconsistencies.
The following data are registered :
- Name, birthname
- Sex
- Date of birth
- Location (town)
- Birth location (town)
- Profession
- Number of siblings
- Marital status
- Number of children
- Date of onset
- Date and nature of clinical manifestations
- MRI reports
- CSF analysis reports
- Event-related potential reports
- Impairment and disability evolution
- Treatments (start and change of drug treatment)
- Drugs related events
- Cause of treatment discontinuation
- Disease progression Every case has a follow up at least every two years.
The quality of data is evaluated by periodically auditing cases at random from our database.
An annual report on the main data (incidence and prevalence) of MS in Lorraine is produced.
Data are also used for observational studies on prognostic factors.
- Conditions
- Multiple Sclerosis
- Being tested
- Observational registry
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational registryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
case occurence of multiple sclerosis
Measured: one year
Secondary outcomes (1)
EDSS score
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMay 2003
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Lorraine
- Responsible party
- Principal investigator, GUILLEMIN Francis, MD, Central Hospital, Nancy, France
- Investigators
- Francis Guillemin, MD, PHD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883335
- Sponsor's protocol ID
- RELSEP
- Acronym
- RelSEP
- Status last verified
- Feb 2023
- First submitted
- 19 Aug 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: open to partnership
Publications
Brissart H, Morele E, Baumann C, Perf ML, Leininger M, Taillemite L, Dillier C, Pittion S, Spitz E, Debouverie M. Cognitive impairment among different clinical courses of multiple sclerosis. Neurol Res. 2013 Oct;35(8):867-72. doi: 10.1179/1743132813Y.0000000232. Epub 2013 Jun 19.
PubMed 23816638Brissart H, Sauvee M, Latarche C, Dillier C, Debouverie M. Integration of cognitive impairment in the expanded disability status scale of 215 patients with multiple sclerosis. Eur Neurol. 2010;64(6):345-50. doi: 10.1159/000322140. Epub 2010 Nov 13.
PubMed 21071951El Adssi H, Debouverie M, Guillemin F; LORSEP Group. Estimating the prevalence and incidence of multiple sclerosis in the Lorraine region, France, by the capture-recapture method. Mult Scler. 2012 Sep;18(9):1244-50. doi: 10.1177/1352458512437811. Epub 2012 Feb 21.
PubMed 22354740Becker M, Latarche C, Roman E, Debouverie M, Malaplate-Armand C, Guillemin F. No prognostic value of routine cerebrospinal fluid biomarkers in a population-based cohort of 407 multiple sclerosis patients. BMC Neurol. 2015 May 13;15:79. doi: 10.1186/s12883-015-0330-4.
PubMed 25966681
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lorraine Registry of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02883335
- Acronym / sponsor ID
- RelSEP / RELSEP
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Lorraine
- Study start
- May 2003
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 30 Aug 2016 (estimated)
- 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.
The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events.
Detailed description
As every patient registry in France, the RelSEP is periodically (every four years) evaluated by an independent committee.
The RelSEP interrogate multiple sources to insure its exhaustiveness :
- every neurologists of Lorraine
- MS patient network in Lorraine
- health insurance data
- PMSI (administrative French national database for hospitals)
- biological and imagery services in Lorraine Procedures (automatic and manual) are used to eliminate duplicates Once a patient has been identified its medical file are checked by investigators in order to retrieve the relevant information.
New MS cases are confirmed by neurologists. Automatics (implemented in EDMUS software)and manual checks are implemented in the registry database, looking for inconsistencies.
The following data are registered :
- Name, birthname
- Sex
- Date of birth
- Location (town)
- Birth location (town)
- Profession
- Number of siblings
- Marital status
- Number of children
- Date of onset
- Date and nature of clinical manifestations
- MRI reports
- CSF analysis reports
- Event-related potential reports
- Impairment and disability evolution
- Treatments (start and change of drug treatment)
- Drugs related events
- Cause of treatment discontinuation
- Disease progression Every case has a follow up at least every two years.
The quality of data is evaluated by periodically auditing cases at random from our database.
An annual report on the main data (incidence and prevalence) of MS in Lorraine is produced.
Data are also used for observational studies on prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from multiple sclerosis in Lorraine
Key inclusion criteria (2 listed)
- Having a confirmed multiple sclerosis diagnosis
- Living in Lorraine (French region)
Key exclusion criteria (1 listed)
- Refusal to be registered
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 |
|---|---|---|
| Observational registry | Other | – |
Primary outcome
case occurence of multiple sclerosis
Time frame: one year
1 secondary outcome
EDSS score
Time frame: 30 years
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 8 Feb 2023.
- Background: PubMed 23816638Brissart H, Morele E, Baumann C, Perf ML, Leininger M, Taillemite L, Dillier C, Pittion S, Spitz E, Debouverie M. Cognitive impairment among different clinical courses of multiple sclerosis. Neurol Res. 2013 Oct;35(8):867-72. doi: 10.1179/1743132813Y.0000000232. Epub 2013 Jun 19.
- Background: PubMed 21071951Brissart H, Sauvee M, Latarche C, Dillier C, Debouverie M. Integration of cognitive impairment in the expanded disability status scale of 215 patients with multiple sclerosis. Eur Neurol. 2010;64(6):345-50. doi: 10.1159/000322140. Epub 2010 Nov 13.
- Results publication: PubMed 22354740El Adssi H, Debouverie M, Guillemin F; LORSEP Group. Estimating the prevalence and incidence of multiple sclerosis in the Lorraine region, France, by the capture-recapture method. Mult Scler. 2012 Sep;18(9):1244-50. doi: 10.1177/1352458512437811. Epub 2012 Feb 21.
- Results publication: PubMed 25966681Becker M, Latarche C, Roman E, Debouverie M, Malaplate-Armand C, Guillemin F. No prognostic value of routine cerebrospinal fluid biomarkers in a population-based cohort of 407 multiple sclerosis patients. BMC Neurol. 2015 May 13;15:79. doi: 10.1186/s12883-015-0330-4.
- Individual participant dataSharing planned: Yes. open to partnership
Related trials for Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Not yet recruitingObservational study
The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment
Multiple Sclerosis
RecruitingObservational study
Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis
Multiple Sclerosis
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
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.
Francis Guillemin, MD, PHD contact
Jonathan Epstein, MD, MSc contact
Francis Guillemin, MD, PHD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Central Hospital, Nancy, France 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 2 inclusion and 1 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 8 Feb 2023. 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 Francis Guillemin, MD, PHD (francis.guillemin@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
case occurence of multiple sclerosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883335, which also lists 4 linked publications.
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 8 Feb 2023.