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Observational Study of Extracellular RNA Biomarkers in Duchenne Muscular Dystrophy

This study is looking for less invasive ways to understand Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (BMD) activity, instead of muscle biopsies. Researchers want to see if they can detect and measure the severity of these conditions by looking at substances called extracellular RNA in your urine and blood samples. They will measure these substances over 4 years. You may be able to join if you are male and at least 5 years old with DMD or BMD confirmed by genetic testing. Control subjects (people without muscular dystrophy) are also needed. The study is currently unclear on its recruitment status and aims to enroll 100 participants.

Study design
This is an observational study aiming to enroll 100 participants. It is not testing a specific drug or intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will have their extracellular RNA measured at 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05016908

Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy

Recruiting
Not specifiedAges 5+Observational
Massachusetts General Hospital
~100 participants
Updated 2025-11-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Extracellular RNA in biofluids
Measured over 4 years

Conditions

Duchenne Muscular Dystrophy

Explore related trials

Becker's Muscular DystrophyDuchenne Muscular Dystrophy

NCT05016908

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusettsno site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Thurman M. Wheeler, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Tamkin Shahraki, MD
[email protected]
617-726-7506
Email the study team

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Eligibility criteria

Inclusion

Subjects with DMD or BMD based on genetic testing. Control subjects are unknown to have 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 biofluid collection: Males age 5 years and older with DMD or BMD; males and females ages 18 years and older without muscular dystrophy.

Exclusion

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.
Use of anti-platelet drugs within 7 days prior to blood draw; use of anticoagulants within 60 days prior to blood draw.
Inability or unwillingness of the subject to give written informed consent.

What this trial measures

  • Extracellular RNA in biofluids4 years

    The extracellular RNA biomarkers in the muscular dystrophy groups will be evaluated and compared with the extracellular RNA content in control groups. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers as measurements of disease activity and severity.