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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) (ReLATE)

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ClinicalTrials.gov Identifier: NCT05845593
Recruitment Status : Recruiting
First Posted : May 6, 2023
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Ampel BioSolutions, LLC

Brief 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.

Condition or disease Intervention/treatment
Lupus Erythematosus, Systemic Other: Decision Support Test

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Actual Study Start Date : November 3, 2023
Estimated Primary Completion Date : November 10, 2024
Estimated Study Completion Date : March 5, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort Intervention/treatment
Group 1
Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus
Other: Decision Support Test
LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE




Primary Outcome Measures :
  1. LuGENE clinical decision support relative to clinical disease activity [ Time Frame: 16 months ]
    The primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical activity (SLEDAI score) Physician Global Assessment (PGA).

  2. LuGENE clinical decision support relative to lab measures [ Time Frame: 16 months ]
    The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE® with standard laboratory measures of lupus (ANA, anti-DNA, anti-RNP and complement components C3 and C4)

  3. LuGENE clinical decision support relative to PROs [ Time Frame: 16 months ]
    The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE with standard evaluation of patient reported outcomes using standard instruments capturing pain, fatigue and Health-Related Quality of Life.


Secondary Outcome Measures :
  1. LuGENE score correlation to Immune Function with Biomarker endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE Score with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).

  2. LuGENE score correlation to Clinical Feature endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE Score with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)

  3. LuGENE score correlation to Quality of Life PROs endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE Score with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))

  4. LuGENE subset membership correlation to Immune Function with Biomarker endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE® determined subset membership with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).

  5. LuGENE subset membership correlation to Clinical Feature endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE® determined subset membership with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)

  6. LuGENE subset membership correlation to Quality of Life PROs endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE® determined subset membership with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))

  7. LuGENE profile correlation to Immune Function with Biomarker endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE® profile with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).

  8. LuGENE profile correlation to Clinical Feature endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE® profile with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)

  9. LuGENE profile correlation to Quality of Life PROs endpoint: [ Time Frame: 16 months ]
    The association of the LuGENE® profile with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))


Other Outcome Measures:
  1. Physician use and satisfaction [ Time Frame: 16 months ]
    Evaluate the patterns of physician use and opinion of value of LuGENE® using a focused questionnaire created for this trial


Biospecimen Retention:   Samples With DNA
Future Research Plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus
Criteria

Inclusion Criteria:

  1. Male or female aged at least 18 years old.
  2. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation
  3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
  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

Exclusion Criteria:

  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. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
  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. Pregnant or lactating.
  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. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05845593


Contacts
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Contact: Claire Dykas 434-296-2675 claire.dykas@ampelbiosolutions.com

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Daniel Wallace         
United States, Connecticut
Yale School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06519
Contact: Fotios Koumpouras    203-785-2454    fotios.koumpouras@yale.edu   
United States, Maryland
University of Maryland School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Violeta Rus    410-706-3205    vrus@umaryland.edu   
United States, Massachusetts
UMASS Memorial Medical Center-Memorial Campus Not yet recruiting
Worcester, Massachusetts, United States, 01605
Contact: Jonathon Kay    508-334-6273    jonathon.kay@umassmemorial.org   
United States, New York
The Hospital for Special Surgery Not yet recruiting
New York, New York, United States, 10021
Contact: Kyriakos Kirou    212-606-1728    kirouk@hss.edu   
United States, Pennsylvania
Temple University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Robert Caricchio       roc@temple.edu   
Sponsors and Collaborators
Ampel BioSolutions, LLC
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Responsible Party: Ampel BioSolutions, LLC
ClinicalTrials.gov Identifier: NCT05845593    
Other Study ID Numbers: AMP-005
First Posted: May 6, 2023    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases