RECRUITING

Adult and Juvenile Myositis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability. Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results. All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures: 1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks 2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic) 3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles 4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow 5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function 6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray 7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart) 8. Endocrine evaluation 9. Eye examination, in patients with vision loss or other eye symptoms 10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste. 11. Muscle ultrasound. 12. Electromyography (record of the electrical activity of muscles) 13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination) All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period. Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing....

Official Title

Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies

Quick Facts

Study Start:1995-06-07
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00017914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient has documented evidence that he/she meets criteria for an idiopathic inflammatory myopathy
  2. 2. Has one of the following conditions:
  3. * Inflammatory and non-inflammatory myopathies:
  4. * Mimicking and related skin disorders:
  5. * Disorders of the complications of myositis (including interstitial lung disease, calcifying disorders, cardiomyopathies, etc.):
  6. * Overlapping autoimmune diseases that may be associated with myositis
  7. * Patients with muscle and/or skin inflammation and documented environmental exposures:
  8. * Patients with myositis or complications of myositis and suspected genetic disorders:
  9. * Patients with undifferentiated connective tissue disease
  10. * Patients with signs or symptoms of myositis (such as weakness, skin rashes, interstitial lung disease) or laboratory abnormalities (such as elevated CK or muscle biopsy with myopathic features) who do not have an established diagnosis of myositis for them to be evaluated to establish a diagnosis
  1. 1. Patients \<2 years or \>100 years will be excluded.
  2. 2. Any conditions in which the drawing of the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.

Contacts and Locations

Study Contact

Lisa G Rider, M.D.
CONTACT
(301) 451-6272
riderl@mail.nih.gov

Principal Investigator

Lisa G Rider, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Environmental Health Sciences (NIEHS)

Study Locations (Sites)

Emory University
Atlanta, Georgia, 30322
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
United States
Texas Scottish Rite Hospital
Dallas, Texas, 75219
United States

Collaborators and Investigators

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

  • Lisa G Rider, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Environmental Health Sciences (NIEHS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1995-06-07
Study Completion DateN/A

Study Record Updates

Study Start Date1995-06-07
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Adult and Pediatric Disease
  • Autoimmunity Pathogenesis
  • Disease Assessment
  • Genetic and Environmental Risk Factors
  • Myositis
  • Natural History

Additional Relevant MeSH Terms

  • Dermatomyositis
  • Polymyositis
  • Inclusion Body Myositis