Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
Public ClinicalTrials.gov record NCT05845593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05845593
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 18, 2023
- Primary completion
- Dec 9, 2024
- Completion
- Mar 4, 2025
- Last update posted
- May 2, 2024
2023 – 2025
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix | Arizona | 85032 | Not yet recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| Providence St. John's Health Center - Rheumatology | Santa Monica | California | 90404 | Not yet recruiting |
| Yale School of Medicine | New Haven | Connecticut | 06519 | Not yet recruiting |
| Rush University Medical Center | Chicago | Illinois | 60612 | Not yet recruiting |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | Not yet recruiting |
| Mayo Clinic | Rochester | Minnesota | 55096 | Not yet recruiting |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | Recruiting |
| The Hospital for Special Surgery | New York | New York | 10021 | Not yet recruiting |
| Arthritis and Osteoporosis Consultants of the Carolinas | Charlotte | North Carolina | 28207 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05845593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 2, 2024 · Synced Sep 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05845593 live on ClinicalTrials.gov.