ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Silicone-Associated Connective Tissue Diseases

This study has been completed.
Study NCT00001330.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Study of Silicone-Associated Connective Tissue Diseases
Official Title  Epidemiologic, Immunologic, and Immunogenetic Factors in Silicone-Associated Connective Tissue Diseases
Brief Summary

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.).

Detailed Description

This multicenter study will attempt to determine the epidemiologic, clinical, serologic and immunogenetic factors associated with patients who develop scleroderma/systemic sclerosis after silicone prosthesis implantation or silicone injection. This will be accomplished by comparing these patients to groups of appropriately matched patients with idiopathic scleroderma/systemic sclerosis without silicone exposure, and appropriately matched volunteers who have received similar silicone implants or injections and have not developed symptoms, physical examination findings, or laboratory abnormalities associated with autoimmune/connective tissue diseases. Patient and physician questionnaires will be self-administered, and will collect data regarding: the number and types of implanted silicone devices or injections; the indications for and nature of the surgical procedures; peri- and post-operative complications; initial and subsequent clinical presentations; and therapy and clinical course of the patients. Routine clinical tests and immunologic laboratory evaluations will be performed. Also, studies will be conducted on the proportion of circulating activated lymphocytes and levels of soluble mediators of inflammation (cytokines, sIL-2R, sCD4, sCD8, TNF), the types of HLA and T cell receptor genes present in the patients, and the presence and titers of anti-silicone antibodies and autoantibodies.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Autoimmune Diseases
Connective Tissue Diseases
Scleroderma, Circumscribed
Scleroderma, Systemic
Intervention 
MEDLINE PMIDs 6691849,   3945681,   3523553
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  60
Start Date  November 1992
Completion Date October 2000
Eligibility Criteria 

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.

Gender Both
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001330
Organization ID 930035
Secondary IDs †† 93-AR-0035
Study Sponsor  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date November 1999
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers