Actively Recruiting
Environmental Risk Factors for the Anti-Synthetase Syndrome in Myositis An Observational Study Comparing Environmental Exposures in Patients With and Without Anti-Synthetase Syndrome
Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-06-08
580
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating environmental factors that may trigger myositis, a disease where the immune system attacks muscle tissue, leading to muscle weakness and other health issues. This study focuses on a specific form called the anti-synthetase syndrome, which involves autoantibodies and often affects the lungs. The goal is to compare environmental exposures before disease onset in people with anti-synthetase syndrome, those with other types of myositis, and healthy volunteers. Participants will be grouped into those with myositis and anti-synthetase syndrome, those with myositis without the syndrome, and healthy controls without autoimmune diseases. The study involves taking medical histories, physical exams, and collecting blood, urine, and house dust samples. Participants will complete detailed questionnaires about their exposures at work, home, and elsewhere. Myositis patients will undergo additional tests like lung function studies and imaging, depending on clinical needs. During the study, participants provide samples and fill out exposure questionnaires, including about infections, exercise, sun exposure, and stress before diagnosis. House dust will be collected using a vacuum filter kit for later analysis. Researchers will measure environmental exposures, immune markers, and clinical assessments to understand differences in triggers among groups. Participation includes consent, sample donation, and completion of questionnaires, with safety monitored throughout the study.
CONDITIONS
Brief Title
Environmental Risk Factors for the Anti-synthetase Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myositis (possible, probable, or definite polymyositis or dermatomyositis), with or without other connective tissue diseases, documented within 24 months before enrollment
- Chest X-ray to assess possible lung disease if clinically indicated
- Children must be older than 2 years
- Able and willing to give informed consent, complete questionnaires, and donate blood samples
- Healthy volunteers matched by race, gender, and age without autoimmune disorders or lung disease
- No gender or ethnic restrictions for enrollment
You will not qualify if you...
- Cancer diagnosed within 2 years of myositis diagnosis (cancer-associated myositis)
- Inclusion body myositis diagnosis
- Myositis caused by drug, toxin, or other exposure that resolved after stopping the agent
- Children younger than 2 years
- Medical illnesses preventing safe blood draws or clinical evaluations
- Cognitive impairment
- Unable or unwilling to provide consent or assent
- Not residing in the US or Canada at reference date
- Currently incarcerated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to a few days depending on clinical needs
Participants undergo clinical, laboratory, and immunologic assessments to document current diagnoses, disease manifestations, and severity. Additional diagnostic procedures such as chest x-rays, high resolution computed tomography (HRCT) of the chest, pulmonary function tests, bronchoalveolar lavage, and muscle and lung biopsies may be performed as clinically indicated.
1 to 2 visits depending on clinical indications
Duration - Ongoing throughout the study period
Participants are observed over time to assess environmental exposures and disease progression. Biospecimen repositories including blood DNA and RNA sera, biopsy samples, and house dust will be collected for current and future investigations.
Visit frequency varies based on study requirements and participant group
Trial Site Locations
Total: 8 locations
1
University of Miami Hospital
Miami, Florida, United States, 33101
Withdrawn
2
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Completed
3
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
4
Mid-Atlantic Kaiser Permanente
Rockville, Maryland, United States, 20853
Completed
5
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Completed
6
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Completed
7
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States, 27709
Actively Recruiting
8
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Completed
Research Team
A
Adam I Schiffenbauer, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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