Lupus Landmark Study: A Prospective Registry and Biorepository
NCT ID: NCT05934149
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3500 participants
OBSERVATIONAL
2023-06-28
2035-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New Onset
Individuals with a new diagnosis of SLE
No interventions assigned to this group
LN Active
Individuals with a recent diagnosis of Lupus Nephritis
No interventions assigned to this group
Extra-renal Flare
Individuals who have experienced a recent flare
No interventions assigned to this group
Prevalent
Individuals with lupus who do not meet the criteria for one of the other cohorts
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 meet protocol visit requirements
* Pregnant at the time of enrollment
18 Years
110 Years
ALL
No
Sponsors
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Lupus Research Alliance
OTHER
Responsible Party
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Principal Investigators
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Sam Lim, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Emory University
Arezou Khosroshahi, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Alfred Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Wallace Rheumatic Studies Center
Beverly Hills, California, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Massachusetts Memorial Health
Worcester, Massachusetts, United States
Washington University
St Louis, Missouri, United States
The Feinstein Institutes for Medical Research
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
Northwell Health
New York, New York, United States
SUNY Upstate
Syracuse, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
The MetroHealth System
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Calgary
Calgary, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
University Health Network/Toronto Western Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LNX-Landmark-001
Identifier Type: -
Identifier Source: org_study_id
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