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NCT05845593 · ClinicalTrials.gov registry record
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
A clinical trial of Lupus Erythematosus, Systemic, sponsored by Ampel BioSolutions.
- Recruiting
- Registry status
- 200
- Enrollment target
- 11
- Study locations
NCT05845593 is a study of Lupus Erythematosus, Systemic that is actively recruiting participants, run by Ampel BioSolutions. The registered enrollment target is 200 participants, roughly in line with the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target. The trial reports 11 study locations across 9 states.
The verdict
NCT05845593, a study of Lupus Erythematosus, Systemic, is actively recruiting participants, sponsored by Ampel BioSolutions.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 11
- Study locations
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 Studied
Interventions
- OTHER Decision Support Test
Study Locations (11)
California
- Cedars-Sinai Medical Center - Los Angeles
- Providence St. John's Health Center - Rheumatology - Santa Monica
New York
- Feinstein Institute for Medical Research - Manhasset
- The Hospital for Special Surgery - New York
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Connecticut
- Yale School of Medicine - New Haven
Illinois
- Rush University Medical Center - Chicago
Maryland
- University of Maryland School of Medicine - Baltimore
Minnesota
- Mayo Clinic - Rochester
North Carolina
- Arthritis and Osteoporosis Consultants of the Carolinas - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-12-19 |
| Est. Completion | 2025-03-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05845593
The ClinicalTrials.gov registry entry for NCT05845593 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target. The listed sponsor is Ampel BioSolutions, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 1 intervention - of which Decision Support Test is the first listed.
NCT05845593 reports 11 study locations spanning 9 distinct geographic areas - top geographies include California, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT05845593 about?
NCT05845593 is a clinical study titled "Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)". 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...
What is the current status of trial NCT05845593?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2023-12-19. Estimated completion is 2025-03-05.
What conditions does trial NCT05845593 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT05845593?
The interventions under investigation include: Decision Support Test (OTHER).
Who is sponsoring clinical trial NCT05845593?
This trial is sponsored by Ampel BioSolutions, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05845593 being conducted?
This trial has 11 study locations across Arizona, California, Connecticut, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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