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Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
Sponsor: Ampel BioSolutions, LLC
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.
Official title: An Open Label Multicenter Study to Assess the Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With Systemic Lupus Erythematosus (SLE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2023-12-19
Completion Date
2025-03-05
Last Updated
2024-05-03
Healthy Volunteers
No
Conditions
Interventions
Decision Support Test
LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE
Locations (11)
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Providence St. John's Health Center - Rheumatology
Santa Monica, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States
The Hospital for Special Surgery
New York, New York, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States