Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-22 @ 1:48 PM
Study NCT ID:
NCT02883335
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lorraine Registry of Multiple Sclerosis
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Lorraine Registry of Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RelSEP
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: