Lupus Landmark Study: A Prospective Registry and Biorepository

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Lupus Nexus Landmark Study: A Prospective Registry and Biorepository

Conditions
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Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Neuropsychiatric Systemic Lupus Erythematosus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and comply with study procedures and voluntarily sign a written informed consent document Age 18 years or older at the time of enrollment Fulfill criteria for SLE based on one or more of the following classifications systems: Systemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 criteria; European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 criteria; 1997 revised ACR criteria; or Lupus is present per clinical assessment. Exclusion Criteria: Not able to obtain consent Not able to meet protocol visit requirements Pregnant at the time of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New Onset<br>Individuals with a new diagnosis of SLE | |
| LN Active<br>Individuals with a recent diagnosis of Lupus Nephritis | |
| Extra-renal Flare<br>Individuals who have experienced a recent flare | |
| Prevalent<br>Individuals with lupus who do not meet the criteria for one of the other cohorts | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 25 years |