Research of Biomarkers in Duchenne Muscular Dystrophy Patients
IBISD
Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients
1 other identifier
observational
220
1 country
1
Brief Summary
The purpose of this study is to identify potential biomarkers for the diagnosis, disease progression assessment and response to treatment in patients with Duchenne Muscular Dystrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 17, 2016
August 1, 2016
4.5 years
June 23, 2011
August 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IBiSD aims to identify and validate new and disease-specific biomarkers.
This study will establish the relevance of urinary and blood biomarkers for the diagnosis, follow-up and assessment of treatment response in patients with DMD (IBiSD1, 2 and 4). IBiSD will also attempt to establish the seroprevalence to the different strains of AAV in patients with DMD (IBiSD3).
End of study
Study Arms (2)
DMD patients
DMD Patients
Control patients
Control patients
Eligibility Criteria
patients with Duchenne Muscular Dystrophy controls (healthy or patients with a non-related disease)
You may qualify if:
- FOR PATIENTS:
- Diagnosis of DMD confirmed by genetic testing
- Age over 3 years
- Weight over 15 kg
- Informed consent signed
- FOR CONTROLS:
- Age over 3 years
- Male gender
- Weight over 15 kg
- Subjects with national health insurance coverage
- Informed consent signed
You may not qualify if:
- FOR PATIENTS:
- Concomitant chronic or acute muscular, endocrine, infectious, allergic or inflammatory disorder in the three weeks preceding the blood test
- Intake of medicines other than angiotensin-converting enzyme inhibitors, beta blockers, dietary supplements, vitamins, alendronate and methylphenidate. Steroids (and medicines prescribed with them such as calcium supplements and proton pump inhibitors) will be discussed
- Mental retardation or autism
- FOR CONTROLS:
- Concomitant chronic or acute muscular, neurological (including mental retardation and autism), infectious or inflammatory disorder in the three weeks preceding the blood test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genethonlead
- Institute of Myologycollaborator
Study Sites (1)
Institute of Myology
Paris, France
Biospecimen
DNA, serum, t lymphocytes, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent SERVAIS, MD
Myology Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 17, 2016
Record last verified: 2016-08