Biomarker Development for Muscular Dystrophies

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: t
View:

• 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.

Locations
United States
Massachusetts
Boston Children's Hospital
ACTIVE_NOT_RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
Wake Forest University
RECRUITING
Winston-salem
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Tamkin Shahraki, MD
tshahraki@mgh.harvard.edu
617-726-7506
Time Frame
Start Date: 2015-02-20
Estimated Completion Date: 2027-06
Participants
Target number of participants: 465
Treatments
Single biofluid collection
We will ask eligible volunteers to provide a single urine sample and undergo a single blood draw.
Serial biofluid and muscle function testing
We will ask eligible volunteers to provide a urine sample, a blood sample, and undergo standard muscle function tests once every six months over a two-year period, and undergo pulmonary function tests and electrocardiogram once per year for two years.
Biofluid and muscle tissue biopsy
We will ask eligible volunteers to provide a urine sample and undergo a muscle biopsy once.
Ultrasound and myography testing
We will ask eligible volunteers to provide a single urine sample, a single blood draw, and undergo ultrasound and electrical impedance myography studies once.
Sponsors
Collaborators: Boston Children's Hospital, Brigham and Women's Hospital, University of Pittsburgh, Wake Forest University
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov