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

This study has been completed.
Sponsor:
Collaborator:
Association Française contre les Myopathies (AFM), Paris
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213629
First received: September 13, 2005
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Polymyositis
Dermatomyositis
 Other: transcriptome analysis
Other: T cell repertoire analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Transcriptome Analysis Through a Dedicated Macro-array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • transcriptome [ Time Frame: at inclusion ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
no arm
no arm
 Other: transcriptome analysis
transcriptome analysis from muscle biopsy
Other: T cell repertoire analysis
blood T cell repertoire analysis

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213629     History of Changes
Other Study ID Numbers: 2003/094/HP
Study First Received: September 13, 2005
Last Updated: February 14, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013