NCT00213629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 16, 2012

Status Verified

February 1, 2012

Enrollment Period

5.7 years

First QC Date

September 13, 2005

Last Update Submit

February 14, 2012

Conditions

PolymyositisDermatomyositis

Keywords

myositiscDNA arraysGenes, T-Cell Receptor beta

Outcome Measures

Primary Outcomes (1)

  • transcriptome

    at inclusion

Study Arms (1)

no arm

OTHER

no arm

Other: transcriptome analysisOther: T cell repertoire analysis

Interventions

transcriptome analysisOTHER

transcriptome analysis from muscle biopsy

no arm
T cell repertoire analysisOTHER

blood T cell repertoire analysis

no arm

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • vasculitis
  • coagulation disorder, impossibility to perform muscle biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Rouen

Rouen, Seine Maritime, 76000, France

Location

MeSH Terms

Conditions

PolymyositisDermatomyositisMyositis

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative Techniques

Study Officials

  • Olivier Boyer, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 16, 2012

Record last verified: 2012-02

Locations

FR(1)