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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00213629
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 16, 2012
Association Française contre les Myopathies (AFM), Paris
Information provided by (Responsible Party):
University Hospital, Rouen

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 Phase
Polymyositis Dermatomyositis Other: transcriptome analysis Other: T cell repertoire analysis Not Applicable

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
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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

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

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

Inclusion Criteria:

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

Exclusion Criteria:

  • vasculitis
  • coagulation disorder, impossibility to perform muscle biopsy

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 identifier (NCT number): NCT00213629

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

Responsible Party: University Hospital, Rouen 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:
cDNA arrays
Genes, T-Cell Receptor beta

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