Research of Biomarkers in Duchenne Muscular Dystrophy Patients (IBISD)

August 16, 2016 updated by: Genethon

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Institute of Myology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
DMD patients
DMD Patients
Control patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBiSD aims to identify and validate new and disease-specific biomarkers.
Time Frame: End of study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genethon

Collaborators

Institute of Myology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEE006.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Duchenne Muscular Dystrophy (DMD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe