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Environmental Risk Factors for the Anti-synthetase Syndrome

Recruitingn/aAges 2 Years - 100 YearsAllNational Institute of Environmental Health Sciencโ€ฆ
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In plain words

What the trial is, and whether it could suit you

Background: * Like other complex diseases, autoimmune diseases are the result of numerous causes, including genetic and environmental factors. Some researchers believe that people who are susceptible to autoimmune disorders develop them when the body reacts to environmental or other factors by creating white blood cells that attack the body s own tissues, which then progresses to autoimmune diseases. These immune-triggered disorders can overlap with one another to some extent, but most autoimmune diseases have certain distinct triggers. * The autoimmune disorder myositis weakens the muscles and may cause other health problems. Environmental exposures associated with myositis include ultraviolet radiation, stressful life events and muscle overexertion, collagen implants, infections such as retroviruses and streptococci bacteria, and certain drugs and chemicals. Some individuals with myos

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๐Ÿ“‹ Eligibility rules (as published)
* INCLUSION CRITERIA: There are no gender or ethnic restrictions to enrollment in the study. Age restrictions for children do apply to enrollment in the study. The inclusion criteria for enrollment of myositis subjects are: 1. Diagnosis of myositis based on criteria for possible, probable or definite PM or DM, with or without other connective tissue diseases, documented within 24 months of enrollment (using the most recent diagnosis date to define the 24-month period). 2. CXR to assess possible ILD and assign the subject to the presumptive anti-synthetase positive or negative category if clinically indicated. 3. Children must be greater than two years of age. 4. Able and willing to give informed consent, to complete the questionnaires and to donate blood samples (in case of children greater than 2 years of age but \<18 years of age, parent/legal guardian must be willing and able to provide informed consent and child will provide assent according to child s maturity level and understanding). The exclusion criteria for myositis subjects are: 1. Cancer-associated myositis (cancer diagnosed within 2 years of the diagnosis of myositis). 2. Inclusion body myositis. 3. Myositis that has clearly developed as the result of a drug, toxin or other exposure and has resolved after discontinuation of the exposure to that agent. 4. Children less than 2 years of age. The inclusion criteria for controls are: 1. Friends or, if friends are not available, cousins of the anti-synthetase-positive myositis patient, or, if friends or cousins are not available, volunteers from the general community (such as the NIH Normal volunteer program), race- gender- and age- (within 5 years for minors and within 10 years for adults) matched, and when possible who is living as close as possible to the geographic area of the myositis patient. 2. Controls should be without a recognized autoimmune disease or ILD. 3. Able and willing to give informed consent, to complete the questionnaires and to donate blood samples (in case of children greater than 2 years of age but \<18 years of age, parent/legal guardian must be willing and able to provide informed consent) and child will provide assent according to child maturity level and understanding). The exclusion criteria for all protocol subjects are: 1. Medical illness that in the judgment of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation. 2. Cognitive impairment. 3. Not able or willing to give informed assent or consent. 4. Children less than 2 years of age. 5. Patients who at their reference date were not in the US or Canada 6. Individuals currently incarcerated HIV considerations: HIV is not an exclusion for affected participants in this study for the two following reasons: 1. It has no impact on study procedures or tests. 2. It may be one of the viral risk factors we are investigating.
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What it tests

  • Not listed
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Where

8 sites
University of Miami Hospital
Miami, United States
Johns Hopkins University
Baltimore, United States
National Institutes of Health Clinical Center
Bethesda, United States
Mid-Atlantic Kaiser Permanente
Rockville, United States
Brigham and Women's Hospital
Boston, United States
Mayo Clinic, Rochester
Rochester, United States
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, United States
University of Pittsburgh
Pittsburgh, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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