Trials / Recruiting
RecruitingNCT05934149
Lupus Landmark Study: A Prospective Registry and Biorepository
Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,500 (estimated)
- Sponsor
- Lupus Research Alliance · Academic / Other
- Sex
- All
- Age
- 18 Years – 110 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2023-06-28
- Primary completion
- 2035-12-01
- Completion
- 2035-12-01
- First posted
- 2023-07-06
- Last updated
- 2026-04-15
Locations
25 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT05934149. Inclusion in this directory is not an endorsement.