Lupus Landmark Study: A Prospective Registry and Biorepository
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Neuropsychiatric Systemic Lupus Erythematosus. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
Overview
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.
Primary outcome measures
- Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses. [Time frame: up to 25 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 19 centers
- University of Alabama at Birmingham — Birmingham
- University of Arizona — Tucson
- Wallace Rheumatic Studies Center — Beverly Hills
- UCLA — Los Angeles
- Georgetown University — Washington D.C.
- University of Miami — Miami
- Emory University — Atlanta
- University of Chicago — Chicago
- … and 11 more centers
Canada · 6 centers
- University of Calgary — Calgary
- University of Alberta Hospital — Edmonton
- University of Manitoba — Winnipeg
- University Health Network/Toronto Western Hospital — Toronto
- McGill University Health Centre — Montreal
- CHU de Québec - Université Laval — Québec
Publications
- Staeva TP, Khosroshahi A, Kim AH, Kelly DD, Fekete MJ, Anyadike K, Baloski A, Barriteau SK, Davis A, Mitchell AM, Nepochatov N, Roesler G, Rawley-Payne M, Apruzzese W, Charbonneau A, Dowd C, Fortin PR, Hoover P, Karp DR, Koumpouras F, Lewis M, Mackay M, Mina-Osorio P, Peschken C, Shaw J, Tipple D, Touma Z, Wang A, Wilson R, Bell S, Lee A, Hurlbert MS, Stimola-Sposaro J, Pascual V, Sanz I, Schafer PMID 42521601
Identifiers
NCT: NCT05934149 · LNX-Landmark-001