ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- Concordance between self collected samples and traditional venous draws
研究概览
简要总结
To explore the potential for use of DxTerity's AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information
详细描述
Explore and demonstrate concordance between self-collected samples and traditional phlebotomist venous draw for DxTerity AIP module and biomarkers like C3, C4, anti dsDNA and CRP in SLE participants with self-reported outcomes and medical record data.
The study will collect blood samples and self-reported information for SLE subjects, up to 5000 participants in Phase I, with a subset of 1000 continuing to Phase II with Medical records. Study participants will be recruited using a combination of digital media (including social media, advertising, bloggers, emails). Enrollment and qualification will be done along with consented retrieval of medical records using a study specific mobile app.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 years or older.
- •Must reside in United States
- •Have a clinical diagnosis of SLE
- •Willingness to consent to provide electronic medical records (EMR)
- •Provide written informed consent and comply with the study procedures.
- •Verified diagnosis (Medical records or /and Physician Questionnaire) for SLE
- •Report one or more of the following (record all that apply):
- •Worsening or changes in symptoms or flare
- •Changes in treatment regimen
- •On standard of care treatment
- •On biologics
排除标准
- •Participants unable to complete study requirements
结局指标
主要结局
Concordance between self collected samples and traditional venous draws
时间窗: 36 months
Percentage of participants with concordant IFN-1 status as assessed by the DxTerity AIP IFN-1 module, concordance between phlebotomy draw and self-collected blood samples.
次要结局
- Longitudinal monitoring(36 months)