Clinical trialNCT05845593UnknownObservational

Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)

SponsorAmpel BioSolutions, LLCEnrollment200Lupus Erythematosus, Systemic

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Arizona Arthritis & Rheumatology Research, Pllc
Phoenix, Arizona, United States
Hani Rashid
Not, yet, recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Daniel Wallace
Recruiting
Providence St. John'S Health Center - Rheumatology
Santa Monica, California, United States
Orrin Troum
Not, yet, recruiting
Yale School of Medicine
New Haven, Connecticut, United States
Fotios Koumpouras
Not, yet, recruiting
Rush University Medical Center
Chicago, Illinois, United States
Meenakshi Jolly
Not, yet, recruiting
University of Maryland School of Medicine
Baltimore, Maryland, United States
Violeta Rus
Not, yet, recruiting
Mayo Clinic
Rochester, Minnesota, United States
Uma Thanarajasingam
Not, yet, recruiting
Feinstein Institute for Medical Research
Manhasset, New York, United States
Cynthia Aranow →
Recruiting
the Hospital for Special Surgery
New York, New York, United States
Kyriakos Kirou
Not, yet, recruiting
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States
Gordon Lam
Recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Emily Littlejohn
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Dec 2023
Primary completion: 10 Dec 2024
Completion: 5 Mar 2025
Last update posted: 3 May 2024
Registered enrollment: 200
Registry id: NCT05845593

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.