Recruiting

Extracellular RNA

Sponsor:

Massachusetts General Hospital

Code:

NCT05016908

Conditions

Duchenne Muscular Dystrophy

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Duchenne Muscular Dystrophy

Study ID

NCT05016908

Start date

Nov 30, 2019

Status verified date

Oct, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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.
  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Biofluid collection

Eligible volunteers will be asked to provide a single urine sample and undergo a single blood draw.

Primary outcome measure

  • Extracellular RNA in biofluids [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Tamkin Shahraki, MD

617-726-7506tshahraki@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Tamkin Shahraki, MD

617-726-7506tshahraki@mgh.harvard.edu

Principal Investigator:

Thurman M. Wheeler, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 24, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-24.