Lorraine Registry of Multiple Sclerosis | NCT02883335

Studies
Lorraine Registry of Multiple Sclerosis

NCT02883335

Sponsor

Central Hospital, Nancy, France

Status

Recruiting

Last Update Posted

Feb 8, 2023Actual

Enrollment

6,000Estimated

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Observational registry

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Jan 2030Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

Aug 19, 2016

First Submission Date that Met QC Criteria

Aug 25, 2016

First Posted Date

Aug 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2023

Last Update Posted Date

Feb 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GUILLEMIN Francis, MD, Médecine coordonateur de module, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV
University of Lorraine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Observational registry	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
case occurence of multiple sclerosis		one year

Secondary Outcomes

Measure	Description	Time Frame
EDSS score		30 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having a confirmed multiple sclerosis diagnosis
Living in Lorraine (French region)

Exclusion Criteria:

Refusal to be registered

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients suffering from multiple sclerosis in Lorraine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francis Guillemin, MD, PHD	Contact			francis.guillemin@chru-nancy.fr
Jonathan Epstein, MD, MSc	Contact			j.epstein@chru-nancy.fr

Overall Officials

Name	Affiliation	Role
Francis Guillemin, MD, PHD	CHRU Nancy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy	Recruiting	Nancy		54000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23816638	Background	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.
21071951	Background	Brissart 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.

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases