Lupus Landmark Study: A Prospective Registry and Biorepository

Recruiting

• Conditions: Lupus Nephritis; Systemic Lupus Erythematosus (SLE); Neuropsychiatric Systemic Lupus Erythematosus

• Registration Number: NCT05934149
• Lead Sponsor: Lupus Research Alliance

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).

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:

* 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.

Study Timeline

• Study First Submitted: 2023-06-23
• Study Start: 2023-06-28
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (20)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, 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; 🇺🇸 Saint Louis, Missouri, United States

The Feinstein Institutes for Medical Research; 🇺🇸 Manhasset, New York, United States

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