[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05845593":3,"trial-entities:NCT05845593":265,"trial-summary:NCT05845593":269},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":44,"sex":72,"minimum_age":73,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":78,"locations":81,"central_contacts":250,"overall_officials":255,"references":256,"see_also_links":261},"NCT05845593","AMP-005","Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)","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)","UNKNOWN","2025-03-05","2024-05","2024-05-03","2023-12-19","Ampel BioSolutions, LLC","INDUSTRY",false,"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.",null,[19],"Lupus Erythematosus, Systemic",[],"OBSERVATIONAL",[],{"count":24,"type":25},200,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"OTHER","Decision Support Test","LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE",[32],"Group 1",[34,38,41],{"measure":35,"description":36,"timeFrame":37},"LuGENE clinical decision support relative to clinical disease activity","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).","16 months",{"measure":39,"description":40,"timeFrame":37},"LuGENE clinical decision support relative to lab measures","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)",{"measure":42,"description":43,"timeFrame":37},"LuGENE clinical decision support relative to PROs","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.",[45,48,51,54,57,60,63,66,69],{"measure":46,"description":47,"timeFrame":37},"LuGENE score correlation to Immune Function with Biomarker endpoint:","The association of the LuGENE Score with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3\u002FC4 levels).",{"measure":49,"description":50,"timeFrame":37},"LuGENE score correlation to Clinical Feature endpoint:","The association of the LuGENE Score with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR\u002FEULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)",{"measure":52,"description":53,"timeFrame":37},"LuGENE score correlation to Quality of Life PROs endpoint:","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))",{"measure":55,"description":56,"timeFrame":37},"LuGENE subset membership correlation to Immune Function with Biomarker endpoint:","The association of the LuGENE® determined subset membership with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3\u002FC4 levels).",{"measure":58,"description":59,"timeFrame":37},"LuGENE subset membership correlation to Clinical Feature endpoint:","The association of the LuGENE® determined subset membership with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR\u002FEULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)",{"measure":61,"description":62,"timeFrame":37},"LuGENE subset membership correlation to Quality of Life PROs endpoint:","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))",{"measure":64,"description":65,"timeFrame":37},"LuGENE profile correlation to Immune Function with Biomarker endpoint:","The association of the LuGENE® profile with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3\u002FC4 levels).",{"measure":67,"description":68,"timeFrame":37},"LuGENE profile correlation to Clinical Feature endpoint:","The association of the LuGENE® profile with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR\u002FEULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)",{"measure":70,"description":71,"timeFrame":37},"LuGENE profile correlation to Quality of Life PROs endpoint:","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))","ALL","18 Years",{"inclusion":75,"exclusion":76,"raw_text":77},[],[],"Inclusion Criteria:\n\n1. Male or female aged at least 18 years old.\n2. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation\n3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician\n4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing\n\nExclusion Criteria:\n\n1. 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\n2. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month\n3. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline\n4. Pregnant or lactating.\n5. 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\n6. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test",[79,80],"ADULT","OLDER_ADULT",[82,101,117,131,146,161,176,191,206,219,235],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":98},"Arizona Arthritis & Rheumatology Research, PLLC","NOT_YET_RECRUITING","Phoenix","Arizona","85032","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Rebecca Martinez","CONTACT","480-350-7655","rebecca.martinez@azarthritis.com",{"name":96,"role":97},"Hani Rashid","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},33.44838,-112.07404,{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":88,"contacts":107,"geoPoint":114},"Cedars-Sinai Medical Center","RECRUITING","Los Angeles","California","90048",[108,112],{"name":109,"role":92,"phone":110,"email":111},"Carla Martinez","310-360-9197","carla@walleemed.com",{"name":113,"role":97},"Daniel Wallace",{"lat":115,"lon":116},34.05223,-118.24368,{"facility":118,"status":84,"city":119,"state":105,"zip":120,"country":88,"contacts":121,"geoPoint":128},"Providence St. John's Health Center - Rheumatology","Santa Monica","90404",[122,126],{"name":123,"role":92,"phone":124,"email":125},"Olga Pimienta","310-449-1999","olga.pimienta@providence.org",{"name":127,"role":97},"Orrin Troum",{"lat":129,"lon":130},34.01949,-118.49138,{"facility":132,"status":84,"city":133,"state":134,"zip":135,"country":88,"contacts":136,"geoPoint":143},"Yale School of Medicine","New Haven","Connecticut","06519",[137,141],{"name":138,"role":92,"phone":139,"email":140},"Julie Heffernan","203-785-6631","julie.heffernan@yale.edu",{"name":142,"role":97},"Fotios Koumpouras",{"lat":144,"lon":145},41.30815,-72.92816,{"facility":147,"status":84,"city":148,"state":149,"zip":150,"country":88,"contacts":151,"geoPoint":158},"Rush University Medical Center","Chicago","Illinois","60612",[152,156],{"name":153,"role":92,"phone":154,"email":155},"Joshlean Fair","312-942-8268","Joshlean_Fair@rush.edu",{"name":157,"role":97},"Meenakshi Jolly",{"lat":159,"lon":160},41.85003,-87.65005,{"facility":162,"status":84,"city":163,"state":164,"zip":165,"country":88,"contacts":166,"geoPoint":173},"University of Maryland School of Medicine","Baltimore","Maryland","21201",[167,171],{"name":168,"role":92,"phone":169,"email":170},"Vinh Nguyen","410-706-6474","BSIATON@SOM.UMARYLAND.EDU",{"name":172,"role":97},"Violeta Rus",{"lat":174,"lon":175},39.29038,-76.61219,{"facility":177,"status":84,"city":178,"state":179,"zip":180,"country":88,"contacts":181,"geoPoint":188},"Mayo Clinic","Rochester","Minnesota","55096",[182,186],{"name":183,"role":92,"phone":184,"email":185},"Amber Woltzen","507-422-6732","woltzen.amber@mayo.edu",{"name":187,"role":97},"Uma Thanarajasingam",{"lat":189,"lon":190},44.02163,-92.4699,{"facility":192,"status":103,"city":193,"state":194,"zip":195,"country":88,"contacts":196,"geoPoint":203},"Feinstein Institute for Medical Research","Manhasset","New York","11030",[197,201],{"name":198,"role":92,"phone":199,"email":200},"Sanita Kandasami","516-562-2401","skandasami@northwell.edu",{"name":202,"role":97},"Cynthia Aranow",{"lat":204,"lon":205},40.79788,-73.69957,{"facility":207,"status":84,"city":194,"state":194,"zip":208,"country":88,"contacts":209,"geoPoint":216},"The Hospital for Special Surgery","10021",[210,214],{"name":211,"role":92,"phone":212,"email":213},"Emily Wu","212-774-2967","wue@hss.edu",{"name":215,"role":97},"Kyriakos Kirou",{"lat":217,"lon":218},40.71427,-74.00597,{"facility":220,"status":103,"city":221,"state":222,"zip":223,"country":88,"contacts":224,"geoPoint":232},"Arthritis and Osteoporosis Consultants of the Carolinas","Charlotte","North Carolina","28207",[225,230],{"name":226,"role":92,"phone":227,"phoneExt":228,"email":229},"Audrey Droppelman","704-631-3342","1170","adroppelman@aocc.md",{"name":231,"role":97},"Gordon Lam",{"lat":233,"lon":234},35.22709,-80.84313,{"facility":236,"status":84,"city":237,"state":238,"zip":239,"country":88,"contacts":240,"geoPoint":247},"Cleveland Clinic","Cleveland","Ohio","44195",[241,245],{"name":242,"role":92,"phone":243,"email":244},"Sandra Hodnick","216-444-6039","hodnics@ccf.org",{"name":246,"role":97},"Emily Littlejohn",{"lat":248,"lon":249},41.4995,-81.69541,[251],{"name":252,"role":92,"phone":253,"email":254},"Claire Dykas","434-296-2675","claire.dykas@ampelbiosolutions.com",[],[257],{"pmid":258,"type":259,"citation":260},"37845772","BACKGROUND","Hubbard EL, Bachali P, Kingsmore KM, He Y, Catalina MD, Grammer AC, Lipsky PE. Analysis of transcriptomic features reveals molecular endotypes of SLE with clinical implications. Genome Med. 2023 Oct 16;15(1):84. doi: 10.1186\u002Fs13073-023-01237-9.",[262],{"label":263,"url":264},"Related Info","https:\u002F\u002Fgenomemedicine.biomedcentral.com\u002Farticles\u002F10.1186\u002Fs13073-023-01237-9",{"nct_id":4,"conditions":266,"biomarkers":268},[267],"Systemic Lupus Erythematosus",[],{"nct_id":4,"found":270,"summary":271,"prompt_version":281},true,{"design":272,"status":273,"heading":274,"summary":275,"follow_up":276,"word_count":277,"commitments":278,"compensation":279,"drugs_mentioned":280},"This is an observational study that plans to include 200 participants. It is an open-label study, meaning both you and the study team will know about the LuGENE® test.","completed","LuGENE® Blood Test and Lupus","This study is looking at how well a new blood test, called LuGENE®, compares to standard ways of checking on lupus (Systemic Lupus Erythematosus or SLE). Researchers want to see if the information from the LuGENE® test matches up with how active your lupus is, your lab results, and how you feel (like pain or fatigue). You could join if you are at least 18 years old and have been diagnosed with lupus or incomplete lupus. The study will look at these connections over 16 months. The goal is to understand if LuGENE® can be a helpful tool for doctors and patients.","The study will look at the relationship between the LuGENE® test and other measures over 16 months.",102,"You would have the LuGENE® blood test administered on one occasion. Your clinical and laboratory features would be evaluated at the same time.","Not stated in the trial record.",[],"v2"]