Lupus Landmark Study: A Prospective Registry and Biorepository
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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:
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New Onset: individuals with a new diagnosis of SLE
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Active Lupus Nephritis: individuals with a recent diagnosis of LN
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Extra-Renal Lupus Flare: individuals who have experienced a recent flare
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| New Onset Individuals with a new diagnosis of SLE |
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| LN Active Individuals with a recent diagnosis of Lupus Nephritis |
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| Extra-renal Flare Individuals who have experienced a recent flare |
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| Prevalent Individuals with lupus who do not meet the criteria for one of the other cohorts |
Outcome Measures
Primary Outcome Measures
- Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses. [up to 25 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to understand and comply with study procedures and voluntarily sign a written informed consent document
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Age 18 years or older at the time of enrollment
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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:
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Not able to obtain consent
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Not able to meet protocol visit requirements
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Pregnant at the time of enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wallace Rheumatic Studies Center | Los Angeles | California | United States | 90048 |
| 2 | Emory University | Atlanta | Georgia | United States | 30303 |
Sponsors and Collaborators
- Lupus Research Alliance
Investigators
- Principal Investigator: Sam Lim, MD, MPH, Emory University
- Principal Investigator: Arezou Khosroshahi, MD, Emory University
- Principal Investigator: Alfred Kim, MD, PhD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LNX-Landmark-001