Lorraine Registry of Multiple Sclerosis (RelSEP)
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|ClinicalTrials.gov Identifier: NCT02883335|
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Other: Observational registry|
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
- Date of birth
- Location (town)
- Birth location (town)
- 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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||6000 participants|
|Target Follow-Up Duration:||30 Years|
|Official Title:||Lorraine Registry of Multiple Sclerosis|
|Study Start Date :||May 2003|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2030|
- case occurence of multiple sclerosis [ Time Frame: one year ]
- EDSS score [ Time Frame: 30 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883335
|Contact: Francis Guillemin, MD, PHDfirstname.lastname@example.org|
|Contact: Jonathan Epstein, MD, MScemail@example.com|
|CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy||Recruiting|
|Nancy, France, 54000|
|Contact: Jonathan Epstein, MD, MSc firstname.lastname@example.org|
|Principal Investigator:||Francis Guillemin, MD, PHD||CHRU Nancy|