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RECRUITING
NCT05845593

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

View on ClinicalTrials.gov

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

Interventions

OTHER

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