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NCT05934149Recruiting

Lupus Landmark Study: A Prospective Registry and Biorepository

Lupus Research Alliance

Start Date

6/28/2023

Completion Date

12/1/2035

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

Age Range: 18 years to 110 years

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

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Conditions

Systemic Lupus Erythematosus (SLE)Lupus NephritisNeuropsychiatric Systemic Lupus Erythematosus

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35205

United States

University of Arizona

Tucson, Arizona 85714

United States

Wallace Rheumatic Studies Center

Beverly Hills, California 90210

United States

UCLA

Los Angeles, California 90024

United States

Georgetown University

Washington D.C., District of Columbia 20057

United States

University of Miami

Miami, Florida 33146

United States

Emory University

Atlanta, Georgia 30322

United States

University of Chicago

Chicago, Illinois 60637

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

University of Massachusetts Memorial Health

Worcester, Massachusetts 01605

United States

Washington University

St Louis, Missouri 63130

United States

The Feinstein Institutes for Medical Research

Manhasset, New York 11030

United States

Columbia University Medical Center

New York, New York 10032

United States

Northwell Health

New York, New York 11021

United States

SUNY Upstate

Syracuse, New York 13210

United States

UNC Chapel Hill

Chapel Hill, North Carolina 27599

United States

The MetroHealth System

Cleveland, Ohio 44109

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

University of Calgary

Calgary, Alberta T2N 1N4

Canada

University of Alberta Hospital

Edmonton, Alberta AB T6G 2X8

Canada

University of Manitoba

Winnipeg, Manitoba

Canada

University Health Network/Toronto Western Hospital

Toronto, Ontario M5G 2C4

Canada

McGill University Health Centre

Montreal, Quebec H3H 2R9

Canada

CHU de Québec - Université Laval

Québec, Quebec G1R 2J6

Canada