The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).
This is a multicenter registry and biorepository conducted in the United States (US) and Canada. The registry will enroll over 3500 individuals with SLE over the course of five years into one of following four cohorts: * New Onset: individuals with a new diagnosis of SLE * Active Lupus Nephritis: individuals with a recent diagnosis of LN * Extra-Renal Lupus Flare: individuals who have experienced a recent flare * Prevalent Cases: individuals with lupus who do not meet the criteria for one of the other cohorts The registry data will include but is not limited to: patient demographics, medical history, clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), social history and determinants of health, and environmental exposures. Participants will also be asked to allow access to their medical records. Biological samples, including whole blood, urine, saliva, stool and tissue will be collected throughout the study. These biospecimens will be used for a broad range of analyses, including genetics, genomics, proteomics, biomarker discovery and microbiome profiling.
Study Type
OBSERVATIONAL
Enrollment
3,500
University of Alabama at Birmingham
Birmingham, Alabama, United States
Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses.
Resource intended to be used to address research questions based upon three categorical time frames (historical, cross-sectional, and longitudinal) with specified scientific topics proposed upon request to access the resources.
Time frame: up to 25 years
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New York, New York, United States
NOT_YET_RECRUITING...and 11 more locations