Study of Silicone-Associated Connective Tissue Diseases
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|ClinicalTrials.gov Identifier: NCT00001330|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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.).
|Condition or disease|
|Autoimmune Diseases Connective Tissue Diseases Scleroderma, Circumscribed Scleroderma, Systemic|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Epidemiologic, Immunologic, and Immunogenetic Factors in Silicone-Associated Connective Tissue Diseases|
|Study Start Date :||November 1992|
|Estimated Study Completion Date :||October 2000|
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): NCT00001330
|United States, Maryland|
|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Bethesda, Maryland, United States, 20892|