Actively Recruiting

Age: 5Years +
All Genders
Healthy Volunteers
NCT05019625

Biomarker Development for Muscular Dystrophies

Led by Massachusetts General Hospital · Updated on 2025-11-24

465

Participants Needed

5

Research Sites

692 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

B

Boston Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Biomarker Development for Muscular Dystrophies

Who Can Participate

Age: 5Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects with DM1 or DM2 based on genetic testing and/or clinical criteria, or controls without muscular dystrophy by history
  • Able to provide informed consent or assent for participation in the study
  • Males and females age 5 years and older for single biofluid collection
  • Males and females age 14 years and older for serial biofluid and muscle function testing with DM1
  • Males and females age 18 to 65 years for biofluid collection and muscle biopsy
  • Males and females age 14 years and older for single biofluid collection, ultrasound, and myography
Not Eligible

You will not qualify if you...

  • History of immunosuppression, coagulopathy, pre-existing liver or kidney disease, documented HIV, or hepatitis B/C
  • 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 interfering with post-procedure care
  • Inability or unwillingness to give written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Active, Not Recruiting

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02129

Actively Recruiting

4

Wake Forest University

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

5

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

T

Tamkin Shahraki, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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