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Clinical Trials/NCT01950897
NCT01950897
Completed
Not Applicable

Establishment of Phenotypic Profiles of Muscular Dystrophies for Understanding Disease Progression, Diagnosis and Development of New Therapies

Wake Forest University Health Sciences1 site in 1 country21 target enrollmentAugust 24, 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscular Dystrophies
Sponsor
Wake Forest University Health Sciences
Enrollment
21
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

Muscular dystrophies are caused by mutations in more than 30 genes, some of them remaining to be identified. Phenotypically, it is known that one specific mutation can affect the expression of several other proteins causing difficulty in diagnosis. Correct genotyping is essential for diagnosis, prognosis and treatment, and relies on a complexed analysis of muscle tissues for phenotype profiles. Our research aims to understand how different gene mutations affect expression of other genes via muscle biopsy samples and establishment of phenotypic profiles for correct diagnosis of individual patients. Establishment of such information will be critical for understanding the progression of different muscular dystrophies and to devise new experimental therapies. This research will also provide vital clues for finding new genes involved in the disease process. Muscle samples may also be used to establish cell cultures for testing drugs and new therapies relevant to the treatment of the muscular dystrophies.

Registry
clinicaltrials.gov
Start Date
August 24, 2005
End Date
June 9, 2015
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Under age 6

Outcomes

Primary Outcomes

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)

Time Frame: Data will be analyzed at one year.

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

Study Sites (1)

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