Actively Recruiting

Age: 2Years - 100Years
All Genders
Healthy Volunteers
NCT01276470

Environmental Risk Factors for the Anti-synthetase Syndrome

Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-05-05

580

Participants Needed

8

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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 myositis also produce proteins in the blood called autoantibodies that react with certain parts of the person s own cells, called synthetases, which are involved in making new proteins. A syndrome called the anti-synthetase syndrome, which includes myositis and lung disease, is associated with having the anti-synthetase autoantibodies. Researchers are interested in studying differences in environmental exposures in individuals with myositis. This study is being conducted to determine if persons with the anti-synthetase syndrome have had different environmental exposures before disease onset compared with other patients with myositis who do not have this syndrome and also compared with healthy volunteers. Objectives: \- To determine whether selected infectious and noninfectious environmental exposures are more common in individuals who have myositis with the anti-synthetase syndrome, compared with healthy volunteers. Eligibility: \- Individuals who have been diagnosed with myositis (with or without anti-synthetase autoantibodies), and healthy volunteers without autoimmune disorders. Design: * Participants will be screened with a full medical history and physical examination, and will provide blood, urine and house dust samples. * Participants will complete questionnaires about their medical history and the types of exposures they have had at work, at home, and elsewhere. Participants who have myositis will also be asked about certain infections, heavy exercise or physical exertion, sun exposure, tobacco and alcohol use, and stressful events prior to being diagnosed with the disease. Healthy volunteers will be asked about the same exposures before the date of diagnosis of disease of the myositis subject to which they have been matched. * Participants will receive a kit that contains instructions and a filter to be put onto their vacuum cleaner to collect house dust in the bedroom. This dust will be kept for possible future analyses of infectious or toxic agents based on the other results from the study. * Individuals with myositis will have other tests as clinically indicated, including lung function tests and imaging studies.

CONDITIONS

Official Title

Environmental Risk Factors for the Anti-synthetase Syndrome

Who Can Participate

Age: 2Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with possible, probable, or definite polymyositis or dermatomyositis within 24 months
  • Chest X-ray performed if clinically indicated to assess lung disease
  • Children must be older than 2 years
  • Able and willing to give informed consent, complete questionnaires, and donate blood samples
  • Controls matched by race, gender, and age, living near the patient, without autoimmune disease or lung disease
  • Controls able and willing to give informed consent, complete questionnaires, and donate blood samples
Not Eligible

You will not qualify if you...

  • Cancer-associated myositis diagnosed within 2 years
  • Inclusion body myositis
  • Myositis caused by drugs, toxins, or exposures that resolved after stopping the agent
  • Children younger than 2 years
  • Medical conditions preventing safe study participation
  • Cognitive impairment
  • Unable or unwilling to give informed consent or assent
  • Not residing in the US or Canada at reference date
  • Currently incarcerated

AI-Screening

AI-Powered Screening

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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

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Research Team

A

Adam I Schiffenbauer, M.D.

CONTACT

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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