Research of Biomarkers in Duchenne Muscular Dystrophy Patients (IBISD)

This study is currently recruiting participants.

Verified June 2011 by Genethon

Sponsor:

Collaborator:

Institute of Myology

Information provided by:

Genethon

ClinicalTrials.gov Identifier:

NCT01380964

First received: June 23, 2011

Last updated: June 29, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 23, 2011
Last Updated Date	June 29, 2011
Start Date ^ICMJE	June 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01380964 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Research of Biomarkers in Duchenne Muscular Dystrophy Patients
Official Title ^ICMJE	Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: DNA, serum, t lymphocytes, urine
Sampling Method	Probability Sample
Study Population	patients with Duchenne Muscular Dystrophy controls (healthy or patients with a non-related disease)
Condition ^ICMJE	Duchenne Muscular Dystrophy (DMD)
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	220
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	3 Years to 20 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01380964
Other Study ID Numbers ^ICMJE	GEE006.10
Has Data Monitoring Committee	No
Responsible Party	Geraldine Honnet, Clinical Development Director, Genethon
Study Sponsor ^ICMJE	Genethon
Collaborators ^ICMJE	Institute of Myology
Investigators ^ICMJE	Not Provided
Information Provided By	Genethon
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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