Lupus Landmark Study: A Prospective Registry and Biorepository
Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
1 other identifier
observational
3,500
2 countries
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2035
April 15, 2026
April 1, 2026
12.4 years
June 23, 2023
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
New Onset
Individuals with a new diagnosis of SLE
LN Active
Individuals with a recent diagnosis of Lupus Nephritis
Extra-renal Flare
Individuals who have experienced a recent flare
Prevalent
Individuals with lupus who do not meet the criteria for one of the other cohorts
Eligibility Criteria
Patients with SLE
You may qualify if:
- 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.
You may not qualify if:
- Not able to obtain consent
- Not able to meet protocol visit requirements
- Pregnant at the time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
University of Arizona
Tucson, Arizona, 85714, United States
Wallace Rheumatic Studies Center
Beverly Hills, California, 90210, United States
UCLA
Los Angeles, California, 90024, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
University of Miami
Miami, Florida, 33146, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial Health
Worcester, Massachusetts, 01605, United States
Washington University
St Louis, Missouri, 63130, United States
The Feinstein Institutes for Medical Research
Manhasset, New York, 11030, United States
Columbia University Medical Center
New York, New York, 10032, United States
Northwell Health
New York, New York, 11021, United States
SUNY Upstate
Syracuse, New York, 13210, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599, United States
The MetroHealth System
Cleveland, Ohio, 44109, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
University of Alberta Hospital
Edmonton, Alberta, AB T6G 2X8, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
University Health Network/Toronto Western Hospital
Toronto, Ontario, M5G 2C4, Canada
McGill University Health Centre
Montreal, Quebec, H3H 2R9, Canada
CHU de Québec - Université Laval
Québec, Quebec, G1R 2J6, Canada
Biospecimen
Whole blood, blood derivatives, urine, stool, saliva, tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2023
First Posted
July 6, 2023
Study Start
June 28, 2023
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2035
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Upon request, data and specimens may be made available after review by study team.
- Access Criteria
- The study team will review requests on an individual basis.
De-identified data and specimens may be provided to other researchers for additional research use.