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Study of Silicone-Associated Connective Tissue Diseases

NCT00001330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2008-03-04

No results posted yet for this study

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.).

Conditions

  • Autoimmune Diseases
  • Connective Tissue Diseases
  • Scleroderma, Circumscribed
  • Scleroderma, Systemic

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    lead NIH

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1992-11-30
Completion
2000-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001330 on ClinicalTrials.gov