Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006134
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-08-03
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:
National Center for Research Resources NCRR
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB-GCRC-617 | None | None | None |