myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies

NCT ID: NCT00213629

Last Updated: 2012-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polymyositis Dermatomyositis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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no arm

no arm

Group Type OTHER

transcriptome analysis

Intervention Type OTHER

transcriptome analysis from muscle biopsy

T cell repertoire analysis

Intervention Type OTHER

blood T cell repertoire analysis

Interventions

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transcriptome analysis

transcriptome analysis from muscle biopsy

Intervention Type OTHER

T cell repertoire analysis

blood T cell repertoire analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* indication of muscle biopsy for diagnostic purpose
* written informed consent

Exclusion Criteria

* vasculitis
* coagulation disorder, impossibility to perform muscle biopsy
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association Française contre les Myopathies (AFM), Paris

OTHER

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Boyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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University Hospital of Rouen

Rouen, Seine Maritime, France

Site Status

Countries

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France

Other Identifiers

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2003/094/HP

Identifier Type: -

Identifier Source: org_study_id

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