RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2023-12-19
Study Completion:2025-03-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05845593

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female aged at least 18 years old.
  2. 2. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation
  3. 3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
  4. 4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing
  1. 1. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk
  2. 2. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
  3. 3. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
  4. 4. Pregnant or lactating.
  5. 5. Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer
  6. 6. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test

Contacts and Locations

Study Contact

Claire Dykas
CONTACT
434-296-2675
claire.dykas@ampelbiosolutions.com

Study Locations (Sites)

Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Providence St. John's Health Center - Rheumatology
Santa Monica, California, 90404
United States
Yale School of Medicine
New Haven, Connecticut, 06519
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
Mayo Clinic
Rochester, Minnesota, 55096
United States
Feinstein Institute for Medical Research
Manhasset, New York, 11030
United States
The Hospital for Special Surgery
New York, New York, 10021
United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Ampel BioSolutions, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-19
Study Completion Date2025-03-05

Study Record Updates

Study Start Date2023-12-19
Study Completion Date2025-03-05

Terms related to this study

Additional Relevant MeSH Terms

  • Lupus Erythematosus, Systemic