Lupus Landmark Study: A Prospective Registry and Biorepository

Lupus Research Alliance

Status

Enrolling

Conditions

Neuropsychiatric Systemic Lupus Erythematosus

Lupus Nephritis

Systemic Lupus Erythematosus (SLE)

Study type

Observational

Funder types

Other

Identifiers

NCT05934149

LNX-Landmark-001

Details and patient eligibility

About

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).

Full 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.

Enrollment

3,500 estimated patients

Sex

All

Ages

18 to 110 years old

Volunteers

No Healthy Volunteers

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