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Recruiting NCT05934149

NCT05934149 Lupus Landmark Study: A Prospective Registry and Biorepository

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Clinical Trial Summary
NCT ID NCT05934149
Status Recruiting
Phase
Sponsor Lupus Research Alliance
Condition Systemic Lupus Erythematosus (SLE)
Study Type OBSERVATIONAL
Enrollment 3,500 participants
Start Date 2023-06-28
Primary Completion 2035-12

Trial Parameters

Condition Systemic Lupus Erythematosus (SLE)
Sponsor Lupus Research Alliance
Study Type OBSERVATIONAL
Phase N/A
Enrollment 3,500
Sex ALL
Min Age 18 Years
Max Age 110 Years
Start Date 2023-06-28
Completion 2035-12

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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).

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

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