Lupus Landmark Study: A Prospective Registry and Biorepository

Lupus Nephritis Clinical Trial

Official title:

Lupus Nexus Landmark Study: A Prospective Registry and Biorepository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934149
• Other study ID #: LNX-Landmark-001
• Status: Recruiting
• Start date: June 28, 2023
• Est. completion date: December 2033

Study information

• Verified date: December 2023
• Source: Lupus Research Alliance
• Contact: Lupus Nexus Director
• Phone: 646-884-6084
• Email: lupusnexus[@]lupusresearch.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 2033
• Est. primary completion date: December 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Lupus Vasculitis, Central Nervous System
• Nephritis
• Neuropsychiatric Systemic Lupus Erythematosus
• Systemic Lupus Erythematosus (SLE)

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago Medicine	Chicago	Illinois
United States	Wallace Rheumatic Studies Center	Los Angeles	California
United States	University of Massachusetts Memorial Health	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lupus Research Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses.	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.	up to 25 years