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Lupus Landmark Study: A Prospective Registry and Biorepository
NCT05934149 · Lupus Research Alliance
In plain English
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Official title
Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 3500 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-06-28
Estimated completion: 2035-12
Last updated: 2026-04-15
Primary outcomes
- • Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses. (up to 25 years)
Sponsor
Lupus Research Alliance · other
Contacts & investigators
ContactLupus Nexus Director · contact · lupusnexus@lupusresearch.org · 646-884-6084
InvestigatorSam Lim, MD, MPH · principal_investigator, Emory University
InvestigatorArezou Khosroshahi, MD · principal_investigator, Emory University
InvestigatorAlfred Kim, MD, PhD · principal_investigator, Washington University School of Medicine
All locations (25)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
University of ArizonaRecruiting
Tucson, Arizona, United States
Wallace Rheumatic Studies CenterRecruiting
Beverly Hills, California, United States
UCLANot Yet Recruiting
Los Angeles, California, United States
Georgetown UniversityNot Yet Recruiting
Washington D.C., District of Columbia, United States
University of MiamiRecruiting
Miami, Florida, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
University of Massachusetts Memorial HealthRecruiting
Worcester, Massachusetts, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
The Feinstein Institutes for Medical ResearchRecruiting
Manhasset, New York, United States
Columbia University Medical CenterNot Yet Recruiting
New York, New York, United States
Northwell HealthRecruiting
New York, New York, United States
SUNY UpstateRecruiting
Syracuse, New York, United States
UNC Chapel HillRecruiting
Chapel Hill, North Carolina, United States
The MetroHealth SystemRecruiting
Cleveland, Ohio, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
University of CalgaryRecruiting
Calgary, Alberta, Canada
University of Alberta HospitalRecruiting
Edmonton, Alberta, Canada
University of ManitobaRecruiting
Winnipeg, Manitoba, Canada
University Health Network/Toronto Western HospitalRecruiting
Toronto, Ontario, Canada
McGill University Health CentreRecruiting
Montreal, Quebec, Canada
CHU de Québec - Université LavalRecruiting
Québec, Quebec, Canada