PolymyositisMYOARRAYNCT00213629
myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies
A study testing transcriptome analysis and T cell repertoire analysis in people with Polymyositis and Dermatomyositis, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Polymyositis, Dermatomyositis
- What is being tested?
- transcriptome analysis and T cell repertoire analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2004to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication of muscle biopsy for diagnostic purpose
- written informed consent
Who cannot join
- vasculitis
- coagulation disorder, impossibility to perform muscle biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Polymyositis, Dermatomyositis
- Being tested
- transcriptome analysis, T cell repertoire analysis
- Keywords
- myositis, cDNA arrays, Genes, T-Cell Receptor beta
- Medical subject headings
- Polymyositis, Dermatomyositis, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcriptome analysisOther
transcriptome analysis from muscle biopsy
T cell repertoire analysisOther
blood T cell repertoire analysis
| Study group | Role | What they receive |
|---|---|---|
| no arm | Other | no arm Receives: Other: transcriptome analysis; Other: T cell repertoire analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
transcriptome
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymyositisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris
- Responsible party
- Sponsor
- Investigators
- Olivier Boyer, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213629
- Sponsor's protocol ID
- 2003/094/HP
- Acronym
- MYOARRAY
- Status last verified
- Feb 2012
- First submitted
- 13 Sep 2005
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptome Analysis Through a Dedicated Macro-array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.
- ClinicalTrials.gov ID
- NCT00213629
- Acronym / sponsor ID
- MYOARRAY / 2003/094/HP
- Conditions
- Polymyositis, Dermatomyositis
- Keywords
- myositis, cDNA arrays, Genes, T-Cell Receptor beta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris
- Study start
- Nov 2004
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no arm | Other | Other: transcriptome analysis, Other: T cell repertoire analysisno arm |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication of muscle biopsy for diagnostic purpose
- written informed consent
Key exclusion criteria (2 listed)
- vasculitis
- coagulation disorder, impossibility to perform muscle biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcriptome analysistranscriptome analysis from muscle biopsy | Other | no arm |
| T cell repertoire analysisblood T cell repertoire analysis | Other | no arm |
Primary outcome
transcriptome
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Boyer, MD, PhD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcriptome analysis and T cell repertoire analysis in people with Polymyositis and Dermatomyositis, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transcriptome (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2012.