Natural History of Inflammatory Muscle Diseases
NCT05738824 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2026-05-13
Summary
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 12 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.
Conditions
- Inflammation In Skeletal Muscle
Sponsors & Collaborators
-
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
lead NIH
Principal Investigators
-
Andrew L Mammen, M.D. · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eligibility
- Min Age
- 12 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-01
- Primary Completion
- 2032-02-25
- Completion
- 2032-02-25
Countries
- United States
Study Locations
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