About this trial
Objective:
To collect information and biospecimens (such as blood, muscle, and skin samples) that will be used to research causes and treatments of inflammatory muscle diseases.
Eligibility:
People aged 2 years and older with suspected or confirmed inflammatory muscle disease. Healthy volunteers aged 18 years and older are also needed.
Design:
Participants will have at least 1 clinic visit. Each visit will last 4 to 8 hours. Some may return for additional visits.
All participants will undergo these procedures (unless they are unable to):
* Physical exam, including blood and urine tests. * Magnetic resonance imaging (MRI) scan of the thigh. Participants will lie still on a table with padding around 1 thigh. The table will slide into a tube. The scan will last for approximately 40 minutes.
Some procedures are optional:
* Muscle biopsy: An area of skin will be numbed. A quarter-inch cut will be made. Several pieces of muscle tissue, about the size of grains of rice, will be removed. * Skin biopsy: An area of skin will be numbed. A piece of skin about a quarter inch in diameter will be removed. * Lymph node biopsy: A small sample of fluid or tissue from a lymph node will taken to check for infection. * Genetic testing. Some of the samples collected may be used for genetic testing.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients with possible inflammatory muscle disease (suspected or confirmed), and healthy volunteers.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments.
Severity of muscle, skin, pulmonary, and joint involvement. Study of the immune dysregulation, transcriptomic changes, and genetic modifications in patients with inflammatory muscle diseases.
Secondary outcomes
Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis.
Utility of standard of care laboratory, radiologic, electrophysiologic, and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.