NCT05019625Recruiting
Biomarker Development for Muscular Dystrophies
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 465 (estimated)
- First submitted
- 16 Aug 2021
- Start date
- 20 Feb 2015
- Primary completion date
- Jun 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT05019625
What you commit to
- Study type: Observational
- Planned participants: 465
- From 20 Feb 2015 to the primary completion date, Jun 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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
- Other. Inability or unwillingness of the subject to give written informed consent.
Who the study is looking for
- 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.
Age in the registry: 5 years to - · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Wake Forest University Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.