myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies

Dermatomyositis Clinical Trial

— MYOARRAY  

Official title:

Transcriptome Analysis Through a Dedicated Macro-array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213629
• Other study ID #: 2003/094/HP
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: February 14, 2012
• Start date: November 2004
• Est. completion date: July 2010

Study information

• Verified date: February 2012
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

• indication of muscle biopsy for diagnostic purpose

• written informed consent

Exclusion Criteria:

• vasculitis

• coagulation disorder, impossibility to perform muscle biopsy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dermatomyositis
• Polymyositis

Intervention

Other:
• transcriptome analysis
transcriptome analysis from muscle biopsy
• T cell repertoire analysis
blood T cell repertoire analysis

Locations

Country	Name	City	State
France	University Hospital of Rouen	Rouen	Seine Maritime

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Association Française contre les Myopathies (AFM), Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transcriptome		at inclusion	No