Back to resultsmyoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies (MYOARRAY)
Primary Purpose
Polymyositis, Dermatomyositis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcriptome analysis
T cell repertoire analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Polymyositis focused on measuring myositis, cDNA arrays, Genes, T-Cell Receptor beta
Eligibility Criteria
Inclusion Criteria: indication of muscle biopsy for diagnostic purpose written informed consent Exclusion Criteria: vasculitis coagulation disorder, impossibility to perform muscle biopsy
Sites / Locations
- University Hospital of Rouen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
no arm
Arm Description
no arm
Outcomes
Primary Outcome Measures
transcriptome
Secondary Outcome Measures
Full Information
NCT ID
NCT00213629
First Posted
September 13, 2005
Last Updated
February 14, 2012
Sponsor
University Hospital, Rouen
Collaborators
Association Française contre les Myopathies (AFM), Paris
1. Study Identification
Unique Protocol Identification Number
NCT00213629
Brief Title
myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies
Acronym
MYOARRAY
Official Title
Transcriptome Analysis Through a Dedicated Macro-array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
Association Française contre les Myopathies (AFM), Paris
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyositis, Dermatomyositis
Keywords
myositis, cDNA arrays, Genes, T-Cell Receptor beta
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no arm
Arm Type
Other
Arm Description
no arm
Intervention Type
Other
Intervention Name(s)
transcriptome analysis
Intervention Description
transcriptome analysis from muscle biopsy
Intervention Type
Other
Intervention Name(s)
T cell repertoire analysis
Intervention Description
blood T cell repertoire analysis
Primary Outcome Measure Information:
Title
transcriptome
Time Frame
at inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
indication of muscle biopsy for diagnostic purpose
written informed consent
Exclusion Criteria:
vasculitis
coagulation disorder, impossibility to perform muscle biopsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Boyer, MD, PhD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Rouen
City
Rouen
State/Province
Seine Maritime
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
Learn more about this trial
myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies
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