Autoimmune DiseasesNCT00001330
Study of Silicone-Associated Connective Tissue Diseases
An observational study of Autoimmune Diseases and Connective Tissue Diseases, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases, Connective Tissue Diseases, Scleroderma, Circumscribed
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1992to Oct 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, 20892
About this study
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:
Read more
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.).
Read the 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.
- Conditions
- Autoimmune Diseases, Connective Tissue Diseases, Scleroderma, Circumscribed, Scleroderma, Systemic
- Keywords
- Autoimmune Diseases, Connective Tissue Disease, Scleroderma, Silicone Device Implants, Silicone Injection, Idiopathic Scleroderma, Myositis, Systemic Sclerosis
- Medical subject headings
- Autoimmune Diseases, Connective Tissue Diseases, Scleroderma, Localized, Scleroderma, Systemic, Scleroderma, Diffuse, Myositis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startNov 1992
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001330
- Sponsor's protocol ID
- 930035
- Other IDs
- 93-AR-0035
- Status last verified
- Nov 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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. doi: 10.1002/art.1780270101.
PubMed 6691849Weiner SR, Paulus HE. Chronic arthropathy occurring after augmentation mammaplasty. Plast Reconstr Surg. 1986 Feb;77(2):185-92. doi: 10.1097/00006534-198602000-00001.
PubMed 3945681Sergott 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. doi: 10.1097/00006534-198607000-00018. No abstract available.
PubMed 3523553
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic, Immunologic, and Immunogenetic Factors in Silicone-Associated Connective Tissue Diseases
- ClinicalTrials.gov ID
- NCT00001330
- Acronym / sponsor ID
- 930035
- Conditions
- Autoimmune Diseases, Connective Tissue Diseases, Scleroderma, Circumscribed, Scleroderma, Systemic
- Keywords
- Autoimmune Diseases, Connective Tissue Disease, Scleroderma, Silicone Device Implants, Silicone Injection, Idiopathic Scleroderma, Myositis, Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Nov 1992
- Study completion
- Oct 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 6691849Kumagai 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. doi: 10.1002/art.1780270101.
- Background: PubMed 3945681Weiner SR, Paulus HE. Chronic arthropathy occurring after augmentation mammaplasty. Plast Reconstr Surg. 1986 Feb;77(2):185-92. doi: 10.1097/00006534-198602000-00001.
- Background: PubMed 3523553Sergott 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. doi: 10.1097/00006534-198607000-00018. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases and Connective Tissue Diseases, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001330, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.