Natural History of Inflammatory Muscle Diseases

Conditions

• Inflammation In Skeletal Muscle

Eligibility Criteria

Sex

ALL

Age

2 Years - 120 Years

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Jun 1, 2023

Status verified

Jun 2026

Primary completion

Feb 25, 2032

Completion

Feb 25, 2032

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: Healthy Volunteers
  18 years old and up
• Arm: Patients
  greater than 2 years old

Primary Outcome Measure

Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments. [ Time Frame: End of each visit ]

Central Contacts

• Julie G Thompson, R.N.
  (301) 480-3191
  [email protected]
• Andrew L Mammen, M.D.
  (301) 594-6667
  [email protected]

Locations (1)

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