Lupus Landmark Study: A Prospective Registry and Biorepository

December 15, 2023 updated by: Lupus Research Alliance

Lupus Nexus Landmark Study: A Prospective Registry and Biorepository

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Wallace Rheumatic Studies Center
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
    • Illinois
    • Massachusetts
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with SLE

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lupus Research Alliance

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Estimated)

December 1, 2033

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNX-Landmark-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data and specimens may be provided to other researchers for additional research use.

IPD Sharing Time Frame

Upon request, data and specimens may be made available after review by study team.

IPD Sharing Access Criteria

The study team will review requests on an individual basis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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