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Lupus Landmark Study: A Prospective Registry and Biorepository

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ClinicalTrials.gov Identifier: NCT05934149
Recruitment Status : Recruiting
First Posted : July 6, 2023
Last Update Posted : December 18, 2023
Sponsor:
Information provided by (Responsible Party):
Lupus Research Alliance

Study Description
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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).

Condition or disease
Systemic Lupus Erythematosus (SLE) Lupus Nephritis Neuropsychiatric Systemic Lupus Erythematosus

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
Actual Study Start Date : June 28, 2023
Estimated Primary Completion Date : December 2033
Estimated Study Completion Date : December 2033

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
New Onset
Individuals with a new diagnosis of SLE
LN Active
Individuals with a recent diagnosis of Lupus Nephritis
Extra-renal Flare
Individuals who have experienced a recent flare
Prevalent
Individuals with lupus who do not meet the criteria for one of the other cohorts


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Whole blood, blood derivatives, urine, stool, saliva, tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with SLE
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05934149


Contacts
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Contact: Lupus Nexus Director 646-884-6084 lupusnexus@lupusresearch.org

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35205
Contact: Jose Rubio Mosquera, MD       jerubiomosquera@uabmc.edu   
Contact: Ellie Laupus       llaupus@uabmc.edu   
United States, California
Wallace Rheumatic Studies Center Recruiting
Los Angeles, California, United States, 90048
Contact: Daniel Wallace, MD, FACP, MACR    310-360-9197    office@walleemed.com   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Arezou Khosroshahi, MD    404-778-6638    akhosroshahi@emory.edu   
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Kimberly Trotter, MD       ksmith14@bsd.uchicago.edu   
Contact: Yusra Irshad       yusra.irshad@bsd.uchicago.edu   
United States, Massachusetts
University of Massachusetts Memorial Health Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Roberto Caricchio, MD       Lupus.Caricchio@umassmed.edu   
Contact: Mohan Pahari       mohan.pahari@umassmed.edu   
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Saira Sheikh, MD       szsheikh@email.unc.edu   
Sponsors and Collaborators
Lupus Research Alliance
Investigators
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Principal Investigator: Sam Lim, MD, MPH Emory University
Principal Investigator: Arezou Khosroshahi, MD Emory University
Principal Investigator: Alfred Kim, MD, PhD Washington University School of Medicine
More Information
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Responsible Party: Lupus Research Alliance
ClinicalTrials.gov Identifier: NCT05934149    
Other Study ID Numbers: LNX-Landmark-001
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data and specimens may be provided to other researchers for additional research use.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Upon request, data and specimens may be made available after review by study team.
Access Criteria: The study team will review requests on an individual basis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Vasculitis, Central Nervous System
Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Glomerulonephritis
Meningoencephalitis
 Central Nervous System Viral Diseases
Central Nervous System Infections
Infections
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Encephalitis
Neuroinflammatory Diseases
Meningitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis