Lupus Landmark Study: A Prospective Registry and Biorepository

Last updated: August 13, 2025
Sponsor: Lupus Research Alliance
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephritis

Lupus

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT05934149
LNX-Landmark-001
  • Ages 18-110
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to understand and comply with study procedures and voluntarily sign a writteninformed consent document

  • Age 18 years or older at the time of enrollment

  • Fulfill criteria for SLE based on one or more of the following classificationssystems:

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

Exclusion Criteria:

  • Not able to obtain consent

  • Not able to meet protocol visit requirements

  • Pregnant at the time of enrollment

Study Design

Total Participants: 3500
Study Start date:
June 28, 2023
Estimated Completion Date:
December 31, 2035

Study 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:

  • 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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 1N4
    Canada

    Active - Recruiting

  • University of Manitoba

    Winnipeg, Manitoba
    Canada

    Active - Recruiting

  • University Health Network/Toronto Western Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montréal, Quebec H3H 2R9
    Canada

    Active - Recruiting

  • CHU de Québec - Université Laval

    Quebec City, Quebec G1R 2J6
    Canada

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • University of Arizona

    Tucson, Arizona 85714
    United States

    Active - Recruiting

  • Wallace Rheumatic Studies Center

    Beverly Hills, California 90210
    United States

    Active - Recruiting

  • Wallace Rheumatic Studies Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33146
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Massachusetts Memorial Health

    Worcester, Massachusetts 01605
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • The Feinstein Institutes for Medical Research

    Manhasset, New York 11030
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Northwell Health

    New York, New York 11021
    United States

    Active - Recruiting

  • SUNY Upstate

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • UNC Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • The MetroHealth System

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

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