Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02881450
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2013-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Study of Inflammatory Myopathies in a French Region
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Prevalence of Inflammatory Myopathies in Alsace
Status:
COMPLETED
Status Verified Date:
2019-08
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:
PREMIA
Brief Summary:
Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January 2012 with "capture-recapture" design using several independent sources of case identification.
Detailed Description:
Inflammatory myopathies (MIs) are a group of muscle diseases with a significant heterogeneity, clinical, immunological and prognosis.
The old classifications, still currently used, highlight this heterogeneity. Therefore Troyanov and coll. and Hoogendijk and coll. have each recently proposed a classification based on clinical and serological - and immuno- histological examination.
The pathogenesis and prognosis of MIs is very different depending on the entity in question.
Knowledge of the descriptive epidemiology of MIs is very limited. In fact no epidemiological work using criteria consensual classification is actually started.
We propose an epidemiological study of MIs. The main objective of the study is to determine the prevalence of MIs in Alsace at 1stJanuary 2012 by means of a "capture- recapture" study using several independent sources of case identification. The secondary objectives of the study are:
* estimating the geographical distribution of the disease in the Alsace region and / or Auvergne
* demographic description of patients : age, sex, residence , occupation
* description of the disease: patient age at diagnosis, disease classification , main clinical manifestations and complications
* Identification of paraneoplastic forms will be for the Alsace region by crossing with Alsatian cancer registries. These records will be interviewed to identify cases of MIs associated with cancers.
The old classifications, still currently used, highlight this heterogeneity. Therefore Troyanov and coll. and Hoogendijk and coll. have each recently proposed a classification based on clinical and serological - and immuno- histological examination.
The pathogenesis and prognosis of MIs is very different depending on the entity in question.
Knowledge of the descriptive epidemiology of MIs is very limited. In fact no epidemiological work using criteria consensual classification is actually started.
We propose an epidemiological study of MIs. The main objective of the study is to determine the prevalence of MIs in Alsace at 1stJanuary 2012 by means of a "capture- recapture" study using several independent sources of case identification. The secondary objectives of the study are:
* estimating the geographical distribution of the disease in the Alsace region and / or Auvergne
* demographic description of patients : age, sex, residence , occupation
* description of the disease: patient age at diagnosis, disease classification , main clinical manifestations and complications
* Identification of paraneoplastic forms will be for the Alsace region by crossing with Alsatian cancer registries. These records will be interviewed to identify cases of MIs associated with cancers.
Study Oversight
Has Oversight DMC:
False
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?: