Biomarker Development for Muscular Dystrophies

  • STATUS
    Recruiting
  • End date
    Jun 26, 2027
  • participants needed
    465
  • sponsor
    Massachusetts General Hospital
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Updated on 26 August 2021
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muscular dystrophy
Accepts healthy volunteers

Summary

Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample, and some muscles in the arms and legs using tests called ultrasound and electrical impedance myography; both tests are painless and non-invasive. The information that is gathered from this study may help to evaluate, prevent, diagnose, treat, and improve the understanding of human muscle diseases.

Details
Condition Facioscapulohumeral muscular dystrophy, Myotonic Dystrophy, DUCHENNE MUSCULAR DYSTROPHY, Muscular Dystrophy
Age 5years - 100years
Clinical Study IdentifierNCT05019625
SponsorMassachusetts General Hospital
Last Modified on26 August 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects with DM1 or DM2 based on genetic testing and/or clinical criteria (some subjects who have positive genetic testing may be asymptomatic, while other subjects who show characteristic clinical features may have declined to have genetic testing done). Control non-DM subjects are unknown to have DM or any other muscular dystrophy by history and may have had no genetic testing
Able to provide informed consent or assent for participation in the study
Demographic characteristics for single biofluid collection: Males and females age 5 years and older
Demographic characteristics for serial biofluid and muscle function testing: Males and females age 14 years and older with DM1
Demographic characteristics for biofluid and muscle biopsy: Males and females, ages 18-65 years
Demographic characteristics for single biofluid collection, ultrasound, and
myography: Males and females age 14 years and older

Exclusion Criteria

Medical history of any of the following. State of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and/or C positive
Medications and other drugs. Use of anti-platelet drugs within 7 days prior to blood draw or biopsy; use of anticoagulants within 60 days prior to blood draw or biopsy; active drug or alcohol use or dependence that, in the opinion of the biopsy surgeon, would interfere with post-procedure wound care
Other. Inability or unwillingness of the subject to give written informed consent
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