Lupus Landmark Study: A Prospective Registry and Biorepository

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).

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Cerebrovascular Disorders Connective Tissue Diseases Encephalitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Infections Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Lupus Vasculitis, Central Nervous System Male Urogenital Diseases Meningitis Meningoencephalitis Nephritis Nervous System Diseases Neuroinflammatory Diseases Neuropsychiatric Systemic Lupus Erythematosus Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lupus Nexus Director

CONTACT

[email protected]

646-884-6084

Sponsors and collaborators

Lead sponsor

Lupus Research Alliance

Other

Registry information

Official study title

Lupus Nexus Landmark Study: A Prospective Registry and Biorepository

Important dates

Study start: 2023
Primary completion: 2035
Study completion: 2035
First posted: Jul 6, 2023
Registry last updated: Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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