LuGENE® Blood Test and Lupus
This study is looking at how well a new blood test, called LuGENE®, compares to standard ways of checking on lupus (Systemic Lupus Erythematosus or SLE). Researchers want to see if the information from the LuGENE® test matches up with how active your lupus is, your lab results, and how you feel (like pain or fatigue). You could join if you are at least 18 years old and have been diagnosed with lupus or incomplete lupus. The study will look at these connections over 16 months. The goal is to understand if LuGENE® can be a helpful tool for doctors and patients.
- Study design
- This is an observational study that plans to include 200 participants. It is an open-label study, meaning both you and the study team will know about the LuGENE® test.
- What's involved
- You would have the LuGENE® blood test administered on one occasion. Your clinical and laboratory features would be evaluated at the same time.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will look at the relationship between the LuGENE® test and other measures over 16 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
At a glance
Conditions
Where it's being run
11 sites across 9 statesWho to contact
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What this trial measures
- LuGENE clinical decision support relative to clinical disease activity16 months
The primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical activity (SLEDAI score) Physician Global Assessment (PGA).
- LuGENE clinical decision support relative to lab measures16 months
The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE® with standard laboratory measures of lupus (ANA, anti-DNA, anti-RNP and complement components C3 and C4)
- LuGENE clinical decision support relative to PROs16 months
The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE with standard evaluation of patient reported outcomes using standard instruments capturing pain, fatigue and Health-Related Quality of Life.