[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659790":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":17,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":66,"collaborators":17,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":17,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":17,"studyType":81,"phases":17,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":93,"whyStopped":17,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Active Genomes Expressed Diagnostics, Corp","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Diagnostic Accuracy of the Blood-Based MASH Prediction Model","The diagnostic performance of the investigational blood-based MASH prediction model will be evaluated by comparing predicted classifications of MASH and simple steatosis with liver biopsy findings. Performance will be assessed using overall diagnostic accuracy, sensitivity, specificity and area under the receiver operating characteristic curve (AUROC) in an independent validation cohort.","From blood sample collection through completion of the independent validation analysis (approximately 12 months)",{"measure":14,"description":15,"timeFrame":16},"Diagnostic Accuracy of the Blood-Based Liver Fibrosis Prediction Model","The diagnostic performance of the investigational blood-based liver fibrosis prediction model will be evaluated by comparing predicted fibrosis stages with liver biopsy findings. Performance will be assessed using overall staging accuracy and the ability to distinguish minimal fibrosis (F0-F1), moderate fibrosis (F2), advanced fibrosis (F3) and cirrhosis (F4) in an independent validation cohort.","From blood sample collection through completion of the independent validation analysis (approximately 12 months).",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","Study Overview:\n\nThis multicenter, prospective, observational study is designed to validate investigational blood-based diagnostic tests developed by AGED Diagnostics for the detection of metabolic dysfunction-associated steatohepatitis (MASH) and the staging of liver fibrosis.\n\nMASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) characterized by fat accumulation, inflammation and injury to liver cells. Over time, MASH can lead to liver fibrosis, cirrhosis and serious liver-related complications. Early identification of MASH and accurate assessment of liver fibrosis are important for determining appropriate clinical management.\n\nCurrent methods for definitively diagnosing MASH generally rely on liver biopsy, an invasive procedure that is not practical for widespread screening or routine disease monitoring. AGED Diagnostics is developing blood-based tests that analyze circulating cell-free DNA (cfDNA) DNA methylation patterns to identify biological signals associated with MASH and different stages of liver fibrosis.\n\nStudy Objectives:\n\nThe primary objective of this study is to independently validate candidate diagnostic prediction models developed during an earlier Verification Study. The study will assess the ability of these models to distinguish patients with simple steatosis from those with MASH and to classify liver fibrosis across stages F0 through F4, ranging from no fibrosis to cirrhosis.\n\nA second objective is to identify the best-performing prediction model for each investigational blood test. The selected models will undergo further evaluation in a subsequent Clinical Utility Study to determine how the tests may support clinical decision-making and improve patient care.\n\nThe investigational tests are being developed with a target overall diagnostic accuracy of at least 90%. This is a development objective and does not represent established clinical performance.\n\nStudy Population and Design:\n\nApproximately 400-500 participants with suspected MASLD will be enrolled across multiple clinical research sites. Eligible participants will have undergone or be scheduled to undergo a liver biopsy as part of their routine clinical evaluation, in accordance with the study's eligibility criteria.\n\nAll participants will be independent of those enrolled in AGED's previous studies.\n\nParticipants will be categorized according to their clinical and liver biopsy findings, including simple steatosis, MASH and relevant additional subgroups. Participants will also be classified according to their stage of liver fibrosis, from F0 to F4. A subset of participants may have metabolic dysfunction and alcohol-associated liver disease (MetALD).\n\nThe study is observational. Blood samples and relevant clinical information will be collected for research purposes. The investigational blood tests will not be used to direct participants' clinical care during this study.\n\nBlood Sample Collection and Analysis:\n\nBlood samples will be collected by trained healthcare professionals using standard venipuncture and study-provided collection kits. Samples will be transported to AGED Diagnostics' central laboratory for processing and analysis.\n\nResearchers will isolate plasma and extract circulating cell-free DNA from the collected blood samples. The DNA will be analyzed using advanced sequencing technology capable of detecting DNA methylation patterns associated with liver disease.\n\nDNA methylation is a naturally occurring chemical modification of DNA that can provide information about the tissues from which circulating DNA originates and their biological state. AGED's investigational tests use selected DNA methylation biomarkers and computational prediction models to identify patterns associated with MASH and different stages of liver fibrosis.\n\nLaboratory processing and data analysis will follow standardized procedures and quality control requirements to support the reliability and consistency of the results.\n\nRelevant demographic information, medical history, laboratory findings and liver biopsy results will be collected through secure electronic case report forms.\n\nStudy Procedures and Analysis:\n\nThe study will be conducted in two principal stages.\n\nStage 1: An interim analysis will be conducted after approximately half of the participants' blood samples have been processed and sequenced. Candidate prediction models will be evaluated for their ability to distinguish simple steatosis from MASH and classify liver fibrosis severity (F0-F4). Based on diagnostic performance, one or two models for each investigational test will be selected for further evaluation, with limited optimization if necessary.\n\nStage 2: The selected models will be evaluated using the remaining participants as an independent validation cohort, with predictions compared against liver biopsy findings. A subsequent analysis of the entire study population will assess overall diagnostic performance across relevant clinical subgroups. Laboratory personnel and the primary analysis team will remain blinded to clinical diagnoses and cohort assignments until the relevant analyses are completed.\n\nExpected Outcomes and Future Research:\n\nThe study will assess the diagnostic performance of AGED's investigational blood tests for identifying MASH and determining the stage of liver fibrosis. The findings will support the selection of final prediction models for further clinical development.\n\nThe selected tests are intended to undergo subsequent clinical utility evaluation to determine whether blood-based diagnosis of MASH and liver fibrosis can improve clinical decision-making, facilitate earlier identification of patients with progressive liver disease and reduce reliance on invasive diagnostic procedures.\n\nThis study is intended to evaluate diagnostic performance and will not assess the effectiveness of a treatment or use investigational test results to guide clinical care.","The study will enroll \\~425 adults with suspected metabolic dysfunction-associated steatotic liver disease (MASLD) who have undergone or are scheduled to undergo a liver biopsy as part of their routine clinical care. Participants will represent a range of disease severity, including simple steatosis, metabolic dysfunction-associated steatohepatitis (MASH), and liver fibrosis stages F0-F4. The study population will include approximately 100 participants with simple steatosis and 325 participants with MASH across varying stages of fibrosis. A subset may have metabolic dysfunction and alcohol-associated liver disease (MetALD). All participants will be independent of those enrolled in previous AGED Diagnostics studies.",[24,27,30,33,36],{"label":25,"type":17,"description":26,"interventionNames":17},"Simple Steatosis","* NASH CRN ≤3\n* Fibrosis stage F0-F1",{"label":28,"type":17,"description":29,"interventionNames":17},"MASH - Group 1","* NASH CRN 4-8\n* Fibrosis stage F0-F1",{"label":31,"type":17,"description":32,"interventionNames":17},"MASH - Group 2","* NASH CRN 4-8\n* Fibrosis stage F2",{"label":34,"type":17,"description":35,"interventionNames":17},"MASH - Group 3","* NASH CRN 4-8\n* Fibrosis stage F3",{"label":37,"type":17,"description":38,"interventionNames":17},"MASH - Group 4","* NASH CRN 4-8\n* Fibrosis stage F4 (cirrhosis)",[40],{"name":41,"affiliation":5,"role":42},"Rachel E Zayas","STUDY_CHAIR",[44],{"name":41,"role":45,"phone":46,"phoneExt":17,"email":47},"CONTACT","617-777-7971","rachel@ageddiagnostics.com",[49],{"facility":50,"status":17,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"AGED Diagnostics Central Lab","Bethesda","Maryland","20852","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-77.10026,38.98067,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":46,"phoneExt":17,"email":65},"Jasmine Kirksey","jasmine@ageddiagnostics.com",{"type":67,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100659790","aged-diagnostics-clinical-validation-study-100659790",false,"NCT07867574","AGED Diagnostics Clinical Validation Study","AGED Diagnostics Clinical Research Study to Validate Liver Disease and Metabolic Associated Disease Biomarkers","Inclusion Criteria for MASLD \\& Fibrosis Patients\n\nPatients must meet all the following inclusion criteria to be eligible for enrollment in the study:\n\n1. Patient is between the ages of 18 and 75.\n2. Patient understands and is willing to sign a written informed consent form (ICF).\n3. Patient has been diagnosed with or is suspected of having MASLD, more specifically, either simple steatosis, metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction and alcohol-associated liver disease (MetALD), or a confirmed or suspected diagnosis of liver fibrosis and are being evaluated for fibrosis stage\n4. Patient has had or will have a diagnostic liver biopsy within 12 months (before or after) being enrolled in the study.\n5. The patient has either undergone PEth testing or a physician will complete the Investigator Confidence Assessment documenting alcohol consumption and the likelihood of MetALD.\n\nExclusion Criteria. Patients with any of the following exclusion criteria are not eligible for enrollment in the study:\n\n1. Patient is unable or unwilling to provide informed consent.\n2. Patient has or has had any form of liver cancer.\n3. Patient is known to have HIV, Hepatitis B or Hepatitis C.\n4. Patient has had a liver transplant at any time.\n5. Patient is on anti-coagulation or anti-platelet therapy other than aspirin, e.g. Coumadin, Pradaxa, Plavix, or heparin.\n6. Patient has been enrolled in a therapeutic clinical trial and has been administered a therapeutic drug as part of that trial.\n7. Patient is on Rezdiffra (resmetirom).\n8. Patients who are currently undergoing dose escalation or who have initiated, discontinued, restarted, switched, or changed the dose of their GLP-1 receptor agonist.","ALL","18 Years","75 Years",{"count":79,"type":80},500,"ESTIMATED","OBSERVATIONAL","Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis:\n\nThis study aims to validate two investigational blood tests developed by AGED Diagnostics for the detection of metabolic dysfunction-associated steatohepatitis (MASH) and the assessment of liver fibrosis (scarring). MASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) that can lead to advanced liver disease, cirrhosis and liver-related complications.\n\nThis prospective, observational study will enroll approximately 400-500 patients with suspected MASLD who are undergoing liver biopsy as part of their clinical care. Researchers will collect blood samples and relevant medical information from participants at multiple clinical sites. The blood samples will be analyzed using advanced DNA sequencing technology to measure DNA methylation, a biological marker that may provide information about liver health.\n\nThe study will evaluate how accurately the investigational blood tests distinguish MASH from simple steatosis (fat accumulation in the liver without MASH) and identify different stages of liver fibrosis. Blood test results will be compared with liver biopsy findings.\n\nThe results will be used to select and validate the most accurate prediction models for future clinical utility studies. The long-term goal is to develop noninvasive blood tests that may help healthcare providers identify patients with MASH and liver fibrosis earlier and guide appropriate clinical care.",[84,85,86,87],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)","Fibrosis and Cirrhosis of Liver","MetALD",[89,90,91,92],"MASLD","MASH","Fibrosis & Cirrhosis of Liver","Fibrosis","NOT_YET_RECRUITING","2026-10-07",{"date":96,"type":97},"2026-10-09","ACTUAL",{"date":99,"type":80},"2026-10-15",{"date":101,"type":80},"2027-12-15",{"name":5,"class":6},1]