Epidemiological Study of Inflammatory Myopathies in a French Region (PREMIA)

August 19, 2019 updated by: University Hospital, Strasbourg, France

Prevalence of Inflammatory Myopathies in Alsace

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Resident of Alsace region located in North-east France

Description

Inclusion Criteria:

  • All patient reported suffering from inflammatory myopathy
  • Meeting the Hoogendijk, Troyanov and Griggs classification criteria
  • Alive at 1st January 2012- Domiciled in Alsace (Bas-Rhin or Haut-Rhin counties of France)

Exclusion Criteria:

  • All patient reported with a different or incomplete diagnosis of inflammatory myopathy (not meeting the Hoogendijk, Troyanov and Griggs criteria)
  • All patient dead and/or non-domiciled in Alsace at 1st January 2012

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimate the prevalence of idiopathic inflammatory myopathies in Alsace.
Time Frame: Prevalence of idiopathic inflammatory myopathies in Alsace at 1st January 2012
Prevalence of idiopathic inflammatory myopathies in Alsace at 1st January 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Jean SIBILIA, MD, University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4963

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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