Muscle Tissue Bank for Muscular Dystrophy

NCT01950897 | Completed

• 1 other identifier: CHS-Neurology-MD Muscle Tissue
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol proposes to establish gene expression profiles of muscular dystrophies for correct diagnosis and for development of experimental therapies for these diseases.

Conditions

Muscular Dystrophies; Muscular Dystrophy

Keywords

muscular dystrophies; muscular dystrophy

Outcome Measures

Primary Outcomes (1)

• Immunohistochemistry for protein expression profiling of skeletal muscle tissue; initial analysis will be qualitative (positive or negative) or semi-quantitative (strong, moderate, weak or negative)

  Samples of MD subjects will be compared to samples of non-muscular dystrophy subjects (i.e. control samples).

  Data will be analyzed at one year.

Study Arms (2)

subjects dx'd clinically w/ muscular dystrophy

subjects with muscular dystrophy from whom muscle samples are obtained for clinical diagnosis or for any other medical purpose

normal controls

subjects who do not have muscular dystrophy and from whom muscle samples are obtained for any medical purpose

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Carolinas Medical Center (CMC) Department of Neurology who meet study criteria.

You may qualify if:

• subjects with or without muscular dystrophy who will be undergoing a diagnostic or therapeutic procedure that involves the removal of a sample of skeletal muscle tissue.
• subjects with or without muscular dystrophy who have had a previous skeletal muscle biopsy performed and where a portion of the muscle sample remains in medical storage are also eligible for this study.

You may not qualify if:

• Under age 6

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center - Dept of Neurology

Charlotte, North Carolina, 28207, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

skeletal muscle tissue

MeSH Terms

Conditions

Muscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Benjamin R Brooks, MD

  Medical Director, Carolinas Neuromuscular/ALS-MDA Center, CMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2013
• First Posted: September 26, 2013
• Study Start: August 24, 2005
• Primary Completion: January 30, 2015
• Study Completion: June 9, 2015
• Last Updated: April 26, 2022

Record last verified: 2019-12

Locations

US (1)