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Environmental Risk Factors for the Development of Myositis in Military Personnel

Open for Recruitment

Study Background

Environmental Risk Factors for the Development of Myositis in Military Personnel

Open for Recruitment

Additional Information

male and female soldier in front of United States Flag
Study Flyer(762KB)

This study attempts to determine if environmental and geographic exposures may be related to the development of myositis during military service and to obtain an initial understanding of the possible mechanisms involved.  Subjects diagnosed with myositis [Dermatomyositis (DM), Polymyositis (PM), or Inclusion Body Myositis (IBM)] while on active duty, and normal volunteers matched to myositis subjects may enroll by completing questionnaires, a physical examination, and donating blood samples.

For more information on this study, please visit the Clinical Trials Study page.

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Eligibility

Inclusion Criteria for Myositis Subjects:

  1. Diagnosis of PM, DM, or IBM during military service. Subjects may be active duty or no longer active duty personnel.  This is based on retrospective review and patients who were formally diagnosed after leaving the military, but had symptoms while active duty may be eligible.  
  2. Able and willing to give informed consent, to complete the questionnaires, and to donate blood samples.

Inclusion Criteria for Matched Control Subjects:

  1. Persons with military experience attending the same clinic or hospital as the myositis subject to which they are matched by gender, race, age, and military service within 10 years.
  2. Control subjects should be without a recognized autoimmune or chronic muscle disease.
  3. Able and willing to give informed consent, to complete the questionnaires, and to donate blood samples.The inclusion criteria for matched controls are: 

Exclusion Criteria for All Subjects:

  1. Medical illness that in the judgment of the investigators does not allow for safe blood draws or other clinical evaluations needed for study participation.
  2. Chronic muscle disease other than idiopathic inflammatory myopathy.
  3. Cognitive impairment.
  4. Not able or willing to give informed consent.
  5. Age <18 years.

What will you do?

Subjects may be enrolled at the NIH Clinical Center in Bethesda, MD, at the NIEHS Clinical Research Unit in Research Triangle Park, NC, or at their local health care provider’s office. A single visit involving a physical examination, blood draw, and data collection is all that is required. Participants enrolling via their local health care provider will receive a study kit in the mail that contains instructions for completing questionnaires and blood draw. Questionnaires are directed to obtain information related to environmental and occupational exposures, as well as quality of life and are based off of questions used from previously approved studies.

All participants will be required to provide medical records for study investigators to confirm diagnosis as a part of the screening process.

Compensation is provided.

What will NIEHS do?

Myositis, an autoimmune muscle disease, likely develops as a result of environmental exposures in genetically susceptible persons. Preliminary data suggests a trend for an increasing incidence in myositis in military personnel over the last decade for unknown reasons. Although a few environmental exposures have been preliminary associated with myositis in the civilian population, these have not been confirmed, and none have been identified in the military. This study consists of three complementary approaches to attempt to link environmental and genetic factors to the development of myositis in military personnel.

The first approach will assess risk factors in a case-control study of 300 patients who developed myositis while on active duty by comparing them to 1500 active duty military personnel who have not been diagnosed with an autoimmune or chronic muscle disease using existing military databases. The second approach will involve the prospective enrollment of subjects to be assessed during a single clinical visit to attempt to define environmental factors associated with the development of myositis that developed in military personnel (n=150) by comparing them to similarly matched healthy military personnel (n=150). The third approach is laboratory based and will explore certain genetic factors and assess the effects of selected environmental exposures on chosen parameters.

Study Location

Subjects may be enrolled at the NIH Clinical Center, 10 Center Drive, Bethesda, MD, 20892, or at the NIEHS Clinical Research Unit, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709, or at your local doctor's office.  Additional sites are in the process of becoming active, contact study members to obtain more information.

Protocol Number: 13-E-0015

Enrollment and Contact Information

Referral/Patient Recruitment
Warren Grant Magnuson Clinical Center
National Institutes of Health
Bethesda, Maryland 20892-2655
Tel 800-411-1222, TTY 866-411-1010
Fax (301) 451-5588
prpl@mail.cc.nih.gov

Principal Investigator

Frederick W. Miller
Frederick W. Miller, M.D., Ph.D.
Deputy Chief, Clinical Research Branch and Principal Investigator
Tel 919-316-4674
Fax 919-451-5585
millerf@mail.nih.gov
P.O. Box 12233
Mail Drop F1-09
Durham, N.C. 27709
Adam I. Schiffenbauer
Adam I. Schiffenbauer, M.D.
Staff Clinician
Environmental Autoimmunity Group, Clinical Research Branch
Tel 301-451-6270
adam.shiffenbauer@nih.gov
10 Center Dr
Clinical Center Surgical Wing
Bethesda, MD 20892-1627

Other Contact

Not Pictured
Komal B. Patel, M.S.
Military Myositis Protocol Coordinator
Tel 301-443-6053
komal.patel@nih.gov
6 Center Drive
Bldg. 6, Rm B112
Bethesda, MD 20892