Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001330
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Study of Silicone-Associated Connective Tissue Diseases
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Epidemiologic Immunologic and Immunogenetic Factors in Silicone-Associated Connective Tissue Diseases
Status:
COMPLETED
Status Verified Date:
1999-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 sclerodermasystemic sclerosis after silicone prosthesis implantation or silicone injection This will be accomplished by comparing these patients to groups of appropriately matched patients with idiopathic sclerodermasystemic 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 autoimmuneconnective 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-AR-0035 | None | None | None |