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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)

NCT05845593 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-05-03

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

OTHER

Decision Support Test

LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE

Sponsors & Collaborators

  • Ampel BioSolutions, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2024-12-10
Completion
2025-03-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845593 on ClinicalTrials.gov