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Research of Biomarkers in Duchenne Muscular Dystrophy Patients (IBISD)

This study has been completed.
Institute of Myology
Information provided by (Responsible Party):
Genethon Identifier:
First received: June 23, 2011
Last updated: August 16, 2016
Last verified: August 2016
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.

Duchenne Muscular Dystrophy (DMD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients

Resource links provided by NLM:

Further study details as provided by Genethon:

Primary Outcome Measures:
  • 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).

Biospecimen Retention:   Samples With DNA
DNA, serum, t lymphocytes, urine

Enrollment: 220
Study Start Date: June 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
DMD patients
DMD Patients
Control patients
Control patients


Ages Eligible for Study:   3 Years to 20 Years   (Child, Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients with Duchenne Muscular Dystrophy controls (healthy or patients with a non-related disease)

Inclusion Criteria:

  • Diagnosis of DMD confirmed by genetic testing
  • Age over 3 years
  • Weight over 15 kg
  • Informed consent signed
  • 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:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01380964

Institute of Myology
Paris, France
Sponsors and Collaborators
Institute of Myology
Principal Investigator: Laurent SERVAIS, MD Myology Institute
  More Information

Responsible Party: Genethon Identifier: NCT01380964     History of Changes
Other Study ID Numbers: GEE006.10 
Study First Received: June 23, 2011
Last Updated: August 16, 2016
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Genethon:
Duchenne Muscular Dystrophy

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked processed this record on October 21, 2016