Research of Biomarkers in Duchenne Muscular Dystrophy Patients (IBISD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Genethon
Sponsor:
Collaborator:
Institute of Myology
Information provided by (Responsible Party):
Genethon
ClinicalTrials.gov Identifier:
NCT01380964
First received: June 23, 2011
Last updated: June 10, 2013
Last verified: June 2011

June 23, 2011
June 10, 2013
June 2011
December 2015   (final data collection date for primary outcome measure)
IBiSD aims to identify and validate new and disease-specific biomarkers. [ Time Frame: End of study ] [ Designated as safety issue: No ]
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).
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Complete list of historical versions of study NCT01380964 on ClinicalTrials.gov Archive Site
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Research of Biomarkers in Duchenne Muscular Dystrophy Patients
Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA, serum, t lymphocytes, urine

Probability Sample

patients with Duchenne Muscular Dystrophy controls (healthy or patients with a non-related disease)

Duchenne Muscular Dystrophy (DMD)
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  • DMD patients
    DMD Patients
  • Control patients
    Control patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Nonacute or chronic muscular, allergic, infectious, endocrine or inflammatory disorder in the 3 weeks preceding inclusion

Exclusion Criteria:

  • 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
  • Vaccination or treatment with immunoglobulins within the three months preceding inclusion
  • 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
  • Vaccination or treatment with immunoglobulins within the three months preceding inclusion
Male
3 Years to 20 Years
Yes
France
 
NCT01380964
GEE006.10
No
Genethon
Genethon
Institute of Myology
Principal Investigator: Laurent SERVAIS, MD Myology Institute
Genethon
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP