Nctid:
NCT06225193
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D005234", "term"=>"Fatty Liver"}], "ancestors"=>[{"id"=>"D008107", "term"=>"Liver Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M8375", "name"=>"Fatty Liver", "asFound"=>"Fatty Liver", "relevance"=>"HIGH"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T5868", "name"=>"Visceral Steatosis", "asFound"=>"Fatty Liver", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M11110", "name"=>"Liver Extracts", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>300}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-06-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06-23", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-26", "studyFirstSubmitDate"=>"2023-11-13", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-23", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Enhanced Liver Fibrosis (ELF )scores", "timeFrame"=>"6 months", "description"=>"Will measure the ELF scores-Reference range 7.14-9.55, the lowest value means better and highest value would mean worst"}, {"measure"=>"Instances of hospital admission for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy", "timeFrame"=>"6 months", "description"=>"Number of hospital admissions for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy"}, {"measure"=>"Demographics", "timeFrame"=>"6 months", "description"=>"age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)"}, {"measure"=>"Instances of comorbidities", "timeFrame"=>"6 months", "description"=>"Patients with hypertension(HTN), Hypersensitivity Lung Disease(HLD), Coronary Artery Disease(CAD),Heart Failure( HF), Atherosclerotic cardiovascular disease (ASCVD), Type 2 Diabetes Mellitus(T2DM) as comorbidities"}], "secondaryOutcomes"=>[{"measure"=>"Abnormalities in Liver ultrasound (U/S) findings", "timeFrame"=>"6 months", "description"=>"rate of liver damage"}, {"measure"=>"Abnormalities in Liver biopsy results", "timeFrame"=>"6 months", "description"=>"Rate of cancerous cells in liver"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Fatty Liver"]}, "descriptionModule"=>{"briefSummary"=>"In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score \\>7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.", "detailedDescription"=>"Methodist Health System consists of nine hospitals and over one hundred clinics that serve 7% to 10% of patients in the Dallas metropolitan. In November 2021, adopted the use of ELF tests in patients who had risk factors for NAFLD/NASH based on abnormal liver enzymes, metabolic risk factors, and evidence of hepatosteatosis on imaging. There is a knowledge gap in the literature when it comes to ELF scores in our population and the data we collect in this study will contribute to filling that knowledge gap.\n\nHistorically, assessment of fibrosis has been accomplished with FibroScan,elastography or liver biopsy. However, these tests are not widely available in most clinics, and can be invasive and costly. At present, the two primary inexpensive and non-invasive alternatives are the fibrosis-4 (FIB-4) and ELF scores, which employ algorithms that utilize routine lab draws. While a low FIB-4 score has a negative predictive value of 90% for advanced fibrosis, it does not provide a risk assessment of liver-related events. For this reason, the study explore the newer ELF serum test as a non-invasive, more affordable and available means to detect patients with developing fibrosis and as a predictor of liver-related outcomes that could be easily used in a primary care setting. This will better risk-stratify this patient population at the primary care level, without need for invasive and expensive testing, and will guide appropriate referrals to Hepatology."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with 18 years of age, NAFLD/NASH and non-NAFLD/NASH who have assessed with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age: ≥ 18 years\n* NAFLD/NASH and non-NAFLD/NASH patients who have had an assessment with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.\n\nExclusion Criteria:\n\n* Patients with incomplete data and those lost to follow up."}, "identificationModule"=>{"nctId"=>"NCT06225193", "briefTitle"=>"Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population", "organization"=>{"class"=>"OTHER", "fullName"=>"Methodist Health System"}, "officialTitle"=>"Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population", "orgStudyIdInfo"=>{"id"=>"022.HEP.2023.D"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75203", "city"=>"Dallas", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Bethany Brauer, MPH", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-4681", "phoneExt"=>"71281"}, {"name"=>"Colette Ngo Ndjom, MS", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"217-947-4681"}, {"name"=>"Parvez Mantry, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Methodist Dallas Medical Center", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}], "centralContacts"=>[{"name"=>"Kavya Vinod Mankulangara, PharmD", "role"=>"CONTACT", "email"=>"MHSIRB@mhd.com", "phone"=>"214-947-4681"}, {"name"=>"Bethany Brauer, MPH", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-4681", "phoneExt"=>"74681"}], "overallOfficials"=>[{"name"=>"Parvez Mantry, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Methodist Midlothian Medical Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Methodist Health System", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
