Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
Status unconfirmed
Conditions studied: Lupus Erythematosus, Systemic
In brief
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.
Key facts
- Study ID
- NCT05845593
- Run by
- Ampel BioSolutions, LLC
- People needed
- 200
- Starts
- 2023-12-19
- Expected to finish
- 2025-03-05
- Last updated by the study team
- 2024-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female aged at least 18 years old.
- Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation
- Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
- On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing
You may not qualify if…
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk
- Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
- Pregnant or lactating.
- Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer
- Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Arthritis and Osteoporosis Consultants of the Carolinas — Charlotte, North Carolina, United States (enrolling)
- Feinstein Institute for Medical Research — Manhasset, New York, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States
- University of Maryland School of Medicine — Baltimore, Maryland, United States
- Mayo Clinic — Rochester, Minnesota, United States
- The Hospital for Special Surgery — New York, New York, United States
- Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Providence St. John's Health Center - Rheumatology — Santa Monica, California, United States
- Yale School of Medicine — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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