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myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies (MYOARRAY)

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ClinicalTrials.gov Identifier: NCT00213629
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 16, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The diagnosis of the different forms of inflammatory myopathies (polymyositis, dermatomyositis, inclusion-body myositis...) remains difficult which may lead to unappropriate patient care.

Objective 1 : to develop and evaluate the diagnostic value of a dedicated DNA-array (myoARRAY) for adult-onset muscular diseases with focus on inflammatory myopathies.

Objective 2 : to evaluate the diagnostic value of T cell repertoire (TcLand) analysis to distinguish different forms of inflammatory myopathies.


Condition or disease Intervention/treatment
Polymyositis Dermatomyositis Other: transcriptome analysis Other: T cell repertoire analysis

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transcriptome Analysis Through a Dedicated Macro-array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.
Study Start Date : November 2004
Primary Completion Date : July 2010
Study Completion Date : July 2010


Arms and Interventions

Arm Intervention/treatment
no arm
no arm
Other: transcriptome analysis
transcriptome analysis from muscle biopsy
Other: T cell repertoire analysis
blood T cell repertoire analysis


Outcome Measures

Primary Outcome Measures :
  1. transcriptome [ Time Frame: at inclusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • indication of muscle biopsy for diagnostic purpose
  • written informed consent

Exclusion Criteria:

  • vasculitis
  • coagulation disorder, impossibility to perform muscle biopsy
Contacts and Locations

Information from the National Library of Medicine

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): NCT00213629


Locations
France
University Hospital of Rouen
Rouen, Seine Maritime, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Association Française contre les Myopathies (AFM), Paris
Investigators
Principal Investigator: Olivier Boyer, MD, PhD University Hospital, Rouen
More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213629     History of Changes
Other Study ID Numbers: 2003/094/HP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012

Keywords provided by University Hospital, Rouen:
myositis
cDNA arrays
Genes, T-Cell Receptor beta

Additional relevant MeSH terms:
Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases