Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,500
- 试验地点
- 40
- 主要终点
- Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not able to obtain consent
- •Not able to meet protocol visit requirements
- •Pregnant at the time of enrollment
研究组 & 干预措施
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
结局指标
主要结局
Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses.
时间窗: 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.
次要结局
未报告次要终点