Clinical trial NCT05934149: Lupus Landmark Study: A Prospective Registry and Biorepository
Official title: Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus (SLE)
Lupus Nephritis
Neuropsychiatric Systemic Lupus Erythematosus
Lead sponsor: Lupus Research Alliance
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with SLE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses.
timeFrame: up to 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Studies Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Memorial Health
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Manhasset
country: United States
facility: The Feinstein Institutes for Medical Research
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: University Health Network/Toronto Western Hospital
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
Study officials:
affiliation: Emory University
name: Sam Lim, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Arezou Khosroshahi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Alfred Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: