Autoimmune Diseases Clinical Trial
Official title:
Epidemiologic, Immunologic, and Immunogenetic Factors in Silicone-Associated Connective Tissue Diseases
This study will examine the possible relationship between silicone implants or injections
and the connective tissue diseases scleroderma and myositis. It will explore whether certain
factors in the blood or the immune system or other factors are involved in the development
of these diseases following silicone implantation or injection.
Men and women 18 years of age and older who meet the following criteria may be eligible for
this study:
Group 1-Patients who have had silicone implants or injections and who later developed
scleroderma or myositis
Group 2-Patients with scleroderma or myositis who have not had silicone implants or
injections
Group 3-Healthy volunteers who have had silicone implants or injections and did not develop
symptoms or other medical features of connective tissue disorders.
Participants will have a thorough history and physical examination, blood and urine tests,
chest X-ray and lung function tests. In addition, patients will complete a questionnaire
about their procedure (including information such as the types of implanted devices and
injections, reason for the procedure, post-operative complications, other illnesses or
medical conditions present before and after the procedure, etc.).
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2000 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
For all groups: Age greater than 18 years; ability to give informed consent. Must not have severe medical disease requiring intensive care or any other conditions in which the drawing of the amount of blood required for research purposes is not deemed medically appropriate by the treating physician or the principal investigator. For Group 1: Patients who have had silicon prostheses, or silicone injection, who subsequently developed scleroderma/systemic sclerosis or myositis as defined by criteria established by the American College of Rheumatology. For Group 2: Patients with idiopathic scleroderma/systemic sclerosis or myositis as defined by criteria established by the American Collage of Rheumatology, without silicone implantation or injection, age-, sex-, and race-matched to Group 1. Group 3: Patients who have had silicone prostheses or silicone injection, age-, sex-, race- and silicone exposure-matched to patients in Group 1, who have not developed chronic symptoms, physical findings, or laboratory abnormalities associated with autoimmune or connective tissue diseases. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Kumagai Y, Shiokawa Y, Medsger TA Jr, Rodnan GP. Clinical spectrum of connective tissue disease after cosmetic surgery. Observations on eighteen patients and a review of the Japanese literature. Arthritis Rheum. 1984 Jan;27(1):1-12. — View Citation
Sergott TJ, Limoli JP, Baldwin CM Jr, Laub DR. Human adjuvant disease, possible autoimmune disease after silicone implantation: a review of the literature, case studies, and speculation for the future. Plast Reconstr Surg. 1986 Jul;78(1):104-14. Review. — View Citation
Weiner SR, Paulus HE. Chronic arthropathy occurring after augmentation mammaplasty. Plast Reconstr Surg. 1986 Feb;77(2):185-92. — View Citation
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