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NCT00342095 · ClinicalTrials.gov registry record
Hormonal and Environmental Risk Factors for Developing Systemic Lupus Erythematosus: The Carolina Lupus (CLU) Study
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 640
- Enrollment target
NCT00342095 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 640 participants.
The verdict
NCT00342095 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 640 participants
- Enrollment target
Study Summary
Systemic lupus erythematosus (SLE) is severe, chronic, disabling autoimmune disease that significantly affects health status and quality of life. Since the disease occurs most often in young to middle-aged adults, SLE can also affect work and disability. However, there is currently little information on work-related disability from longitudinal, population-based studies of SLE. Participants were enrolled into the Carolina Lupus Study between February, 1997 and July 1999. We plan to conduct two telephone contacts with patients and one telephone contact with controls in a follow-up study to be conducted in 2001. The first patient contact will follow an introductory letter that describes the follow-up study. This letter provides participants the opportunity (via a toll-free phone number) to decline further contact about this study. The first patient contact will be a short (5 minute) interview in which we determine their current source of lupus-related medical care, timing of next expected visit, and update contact information. The second contact will involve a 60-minute telephone interview covering medical care utilization, current health status (including a patient-administered measure of lupus activity), work and disability issues, psychosocial attributes (e.g. helplessness, social support, daily stressors including race-related issues), and changes in exposures since the initial interview. We will attempt to schedule the patients' interviews within 3 months before or after the patient sees his or her own physician for SLE-related evaluation or treatment. A short (15 minutes or less) telephone interview will be conducted with controls focusing on current health, work status, and daily stresso. Ddisease damage will be assessed using the System Lupus international Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index, a standardized and validated instrument that is completed by the patient's physician. We will seek death certificates for
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 1996-12-17 |
| Est. Completion | 2007-03-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00342095
The ClinicalTrials.gov registry entry for NCT00342095 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 640 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00342095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00342095 about?
NCT00342095 is a clinical study titled "Hormonal and Environmental Risk Factors for Developing Systemic Lupus Erythematosus: The Carolina Lupus (CLU) Study". Systemic lupus erythematosus (SLE) is severe, chronic, disabling autoimmune disease that significantly affects health status and quality of life. Since the disease occurs most often in young to middle-aged adults, SLE can also affect work and disability. However, there is currently little informatio...
What is the current status of trial NCT00342095?
This trial is currently completed. The enrollment target is 640 participants. The study started on 1996-12-17. Estimated completion is 2007-03-07.
Who is sponsoring clinical trial NCT00342095?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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