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NCT00001330 · ClinicalTrials.gov registry record

Study of Silicone-Associated Connective Tissue Diseases

A clinical trial of Autoimmune Diseases and Scleroderma, Systemic, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Completed
Registry status
60
Enrollment target
1
Study location

NCT00001330 is a study of Autoimmune Diseases and Scleroderma, Systemic that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 60 participants, below the 976-participant average among 25 other Autoimmune Diseases trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001330, a study of Autoimmune Diseases and Scleroderma, Systemic, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

COMPLETED
Registry status
60 participants
Enrollment target
1
Study location

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.).

Study Locations (1)

Maryland

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

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 1992-11
Est. Completion 2000-10

What the Registry Record Tells You About NCT00001330

The ClinicalTrials.gov registry entry for NCT00001330 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 976-participant average among 25 other Autoimmune Diseases trials with a reported enrollment target (94% lower). The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Autoimmune Diseases appearing as the primary indexed condition, and to 0 interventions.

NCT00001330 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001330 about?

NCT00001330 is a clinical study titled "Study of 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 followin...

What is the current status of trial NCT00001330?

This trial is currently completed. The enrollment target is 60 participants. The study started on 1992-11. Estimated completion is 2000-10.

What conditions does trial NCT00001330 study?

This clinical trial studies the following conditions: Autoimmune Diseases, Scleroderma, Systemic, Connective Tissue Diseases, Scleroderma, Circumscribed.

Who is sponsoring clinical trial NCT00001330?

This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001330 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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