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Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture Clinical research trials and Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture. Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture  Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture
Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture
For Condition: Systemic Lupus Erythematosus
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , UAB Comprehensive Cancer Center
Synopsis: OBJECTIVES: I. Continue yearly ascertainment visits of all patients of the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) study cohort. II. Recruit into the LUMINA cohort newly diagnosed patients with systemic lupus erythematosus (SLE). III. Determine the impact of additional major histocompatibility complex (MHC) and non-MHC genetic factors not previously examined, specifically tumor necrosis factor, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2, on the course and outcome of SLE. IV. Refine the assessment of those clinical and behavioral-cultural factors found to be important predictors of disease activity, damage, and functioning, thus far in these patients. V. Determine the relationships among disease activity, disease damage, and physical and mental functioning in these patients as the SLE progresses and the factors that predict them.
Details: PROTOCOL OUTLINE: This is a parallel, follow up study of a natural history study. Patients are stratified according to ethnicity (Caucasian vs African-American vs Hispanic). Patients are examined at baseline and then every 6 months thereafter in order to determine the relative impact of genetic, sociodemographic, and behavioral-cultural factors on disease outcome. Patients are assessed for the following outcome variables: disease activity by the Systemic Lupus Activity Measure (SLAM), disease damage by the Systemic Lupus International Collaborative Clinics Damage Index (SDI), and physical and mental functioning by the Medical Outcomes Study 36 Item Short-Form Health Survey (SF-36). Patients are also assessed for independent variables belonging to the following domains: socioeconomic-demographic, clinical, immunogenetic, and behavioral-cultural. Patients undergo genetic analysis utilizing polymerase chain reaction and electrophoresis to further study the immunogenetic domain and genetic markers that may be related to disease. Specifically, patients' blood is analyzed for tumor necrosis factor alpha, tumor necrosis factor beta, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - All systemic lupus erythematosus (SLE) patients currently constituting the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) cohort OR New recruits meeting at least 4 of the 1997 American College of Rheumatology criteria for the classification of SLE - Disease onset within the past 5 years - African-American, Hispanic, or Caucasian Self stated, plus the same for all 4 grandparents - No concurrent participation in any intervention studies - Not pregnant - Not mentally retarded - No prisoners - No other concurrent disability that would preclude study
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
GracielaAlarcon, Study Chair, UAB Comprehensive Cancer Center
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
University of Texas Health Science Center - Houston
Houston, Texas, 77225
United States
Additional Information:
Study ID Numbers: 199/15328; UAB-GCRC-617
Study Start Date: September 1993
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006134
Other Systemic Lupus Erythematosus Studies:
1. Ultraviolet Light Therapy for Systemic Lupus Erythematosus
2. Study of GL701 in Men with Systemic Lupus Erythematosus
3. Drug Therapy in Lupus Nephropathy
4. Safety of Estrogens in Lupus: Hormone Replacement Therapy
5. Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases
Related Studies:
Other Systemic Lupus Erythematosus Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture
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