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Extracellular RNA Biomarkers of Myotonic Dystrophy

Massachusetts General Hospital · with Beth Israel Deaconess Medical Center, University of Texas · NCT05020002

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
215
US sites recruiting
3
Study start
December 8, 2020
Record last updated
November 24, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Conditions: Myotonic Dystrophy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 (DM1, DM2, and non-DM).
  • Demographic characteristics for repeated measurements: Males and females age 14 years and older with DM1.
  • Demographic characteristics for biofluid and muscle biopsy: Males and females, ages 18-65 years.

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. Women that are pregnant, or intend to become pregnant, prior to the biopsy; urine pregnancy test that is positive; inability or unwillingness of the subject to give written informed consent.
  • Other. Inability or unwillingness of the subject to give written informed consent or assent.

Recruiting US locations

  • Massachusetts General Hospital

    Boston, MA 02129

    Site contact: Tamkin Shahraki, MD · 617-726-7506 · tshahraki@mgh.harvard.edu

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Sarah Verga · sverga@bidmc.harvard.edu

  • University of Texas Southwestern

    Dallas, TX 75390

    Site contact: Karla Castro · 214-456-3696 · karla.castroochoa@utsouthwestern.edu

Study contacts (from the official record)

  • Tamkin Shahraki, MD · 617-726-7506 · tshahraki@mgh.harvard.edu
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Extracellular RNA Biomarkers of Myotonic Dystrophy (NCT05020002) | Bored Studies