Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 4:39 PM
Study NCT ID:
NCT00006134
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture
Sponsor:
National Center for Research Resources (NCRR)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UAB-GCRC-617 | None | None | View |