myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies

This study is currently recruiting participants.

Verified by University Hospital, Rouen, November 2008

Sponsors and Collaborators:	University Hospital, Rouen Association Française contre les Myopathies
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213629

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

MedlinePlus related topics: Muscle Disorders Myositis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Transcriptome Analysis Through a Dedicated Macro-Array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

transcriptome [ Time Frame: at inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2004
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (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:

connective disorder
vasculitis
ancient myositis treated by immunosuppressive regimen
coagulation disorder, impossibility to perform muscle biopsy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213629

Contacts

Contact: Isabelle Marie, MD, PhD

isabelle.marie@chu-rouen.fr

Locations

France, Seine Maritime
University Hospital of Rouen	Recruiting
Rouen, Seine Maritime, France, 76000
Contact: Isabelle Marie, MD, PhD isabelle.marie@chu-rouen.fr
Principal Investigator: Olivier Boyer, MD, PhD

Sponsors and Collaborators

University Hospital, Rouen

Association Française contre les Myopathies

Investigators

Principal Investigator:

Olivier Boyer, MD, PhD

University Hospital, Rouen

More Information

Responsible Party:	Rouen University Hospital ( Prof Isabelle MARIE )
Study ID Numbers:	PHRC 2003 / 094 / HP
Study First Received:	September 13, 2005
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00213629
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Rouen:

myositis
cDNA arrays
Genes, T-Cell Receptor beta

Study placed in the following topic categories:

Myositis
Dermatomyositis
Muscular Diseases
Skin Diseases
Neuromuscular Diseases

Musculoskeletal Diseases
Connective Tissue Diseases
Polymyositis
Idiopathic myopathy

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009