Environmental Risk Factors for Myositis in Military Personnel
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01734369|
Recruitment Status : Recruiting
First Posted : November 27, 2012
Last Update Posted : April 12, 2021
- Myositis is a rare disease in which the body s immune cells attack the muscle tissue. It can cause muscle weakness, swelling, and pain. It can develop in people with no history of muscle problems. Environmental exposures may determine who develops myositis. Genes may also affect development of the disease.
- Some people who serve in the military develop myositis. However, other military personnel do not. Researchers want to compare military personnel with and without myositis. They will look for common factors that might have led to the disease.
- To study environmental risk factors for myositis in military personnel.
- Military personnel who developed myositis during their period of service.
- Healthy military personnel who do not have myositis or another autoimmune disease.
- Participants will have a physical exam and medical history.
- Participants will fill out forms about environmental exposures, particularly while in the military. The questions will ask about past infections, vaccines and medications, and personal habits. They will also ask about participants occupations during military service and their deployments.
- Participants will also provide blood samples for study.
- No treatment will be provided as part of this study.
|Condition or disease|
|Dermatomyositis Adult Polymyositis Inclusion Body Myositis Myositis|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Environmental Risk Factors for the Development of Myositis in Military Personnel|
|Actual Study Start Date :||March 13, 2014|
|Estimated Primary Completion Date :||September 14, 2021|
|Estimated Study Completion Date :||September 14, 2021|
- Military Myositis Questionnaire [ Time Frame: Time of enrollment ]Myositis and control subjects will complete the environmnetal exposure questionnaire, a connective tissue screening questionnaire and the Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life measure to assess health related quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734369
|Contact: Adam I Schiffenbauer, M.D.||(301) email@example.com|
|United States, Alabama|
|Birmingham VA Medical Center||Recruiting|
|Birmingham, Alabama, United States|
|United States, Florida|
|Miami VA Healthcare System||Recruiting|
|Miami, Florida, United States|
|Contact: Dana Ascherman, M.D. 305-575-7000 DAscherman@med.miami.edu|
|United States, Maryland|
|Walter Reed National Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20301|
|Contact: Jess Edison 301-295-4512|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|United States, Pennsylvania|
|VA Pittsburgh Healthcare Sys.||Recruiting|
|Pittsburgh, Pennsylvania, United States|
|United States, Virginia|
|Naval Medical Center, Portsmouth||Recruiting|
|Portsmouth, Virginia, United States, 23708|
|Contact: Shauna O'Sullivan 757-953-2160 email@example.com|
|United States, Washington|
|Madigan Army Medical Center||Recruiting|
|Tacoma, Washington, United States|
|Principal Investigator:||Frederick W Miller, M.D.||National Institute of Environmental Health Sciences (NIEHS)|