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Clinical Trial Summary

This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life. The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE® laboratory results do not exceed more than 7 business days.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05845593
Study type Observational
Source Ampel BioSolutions, LLC
Contact Claire Dykas
Phone 434-296-2675
Email claire.dykas@ampelbiosolutions.com
Status Recruiting
Phase
Start date December 19, 2023
Completion date March 5, 2025

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