- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213629
myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies (MYOARRAY)
Transcriptome Analysis Through a Dedicated Macro-array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Seine Maritime
-
Rouen, Seine Maritime, France, 76000
- University Hospital of Rouen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- indication of muscle biopsy for diagnostic purpose
- written informed consent
Exclusion Criteria:
- vasculitis
- coagulation disorder, impossibility to perform muscle biopsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: no arm
|
transcriptome analysis from muscle biopsy
blood T cell repertoire analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
transcriptome
Time Frame: at inclusion
|
at inclusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Olivier Boyer, MD, PhD, University Hospital, Rouen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003/094/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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