[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658279":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":37,"overallOfficials":17,"centralContacts":45,"locations":55,"responsibleParty":69,"collaborators":17,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":17,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":17,"enrollmentInfo":83,"targetDuration":17,"studyType":86,"phases":17,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":58,"whyStopped":17,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Beijing Municipal Administration of Hospitals","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic Performance of the InstaSure™ Non-Invasive Finger-Press Test for HCC","Diagnostic performance of the InstaSure™ test for distinguishing participants with HCC from non-HCC controls will be evaluated using sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy, with the clinical reference diagnosis used as the reference standard.","Day 1 (at the time of study testing)",[14],{"measure":15,"description":16,"timeFrame":12},"Area Under the Receiver Operating Characteristic Curve (AUC)","The area under the receiver operating characteristic curve (AUC) will be calculated to evaluate the ability of the InstaSure™ test to discriminate participants with HCC from non-HCC controls.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"CASE_CONTROL","RETROSPECTIVE","The study will enroll 40 participants from Beijing Ditan Hospital, Capital Medical University, including 30 patients with hepatocellular carcinoma (HCC), 5 patients with benign liver disease, and 5 healthy controls. HCC will be confirmed by histopathological diagnosis or clinical imaging diagnosis according to established diagnostic criteria. Finger-tip skin cell samples will be collected using a non-invasive finger-press procedure and tested with the InstaSure™ test for HCC-associated CCND1 and CDKN2A\u002FP16 eccDNA signals. Test results will be compared with the clinical reference diagnosis to estimate sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and the Youden index. The study will also evaluate sampling convenience, testing time, and clarity of result interpretation, and explore associations between eccDNA signals and HCC clinical characteristics such as tumor stage, tumor size, and AFP level. The findings will be used as exploratory evidence to support sample-size estimation and procedural optimization for subsequent larger-scale clinical studies.","The study population will consist of adults aged 18 years or older recruited from the outpatient and inpatient populations of the Liver Disease Center at Beijing Ditan Hospital, as well as hospital staff. The study includes three groups: participants with hepatocellular carcinoma (HCC), participants with benign liver disease without HCC, and healthy controls without a history of liver disease.",[24,29,33],{"label":25,"type":17,"description":26,"interventionNames":27},"HCC Group","Participants with hepatocellular carcinoma (HCC) confirmed by histopathology or clinical imaging according to established diagnostic criteria. A total of 30 participants are planned for this group.",[28],"Diagnostic Test: InstaSure™ Non-Invasive Finger-Press Test",{"label":30,"type":17,"description":31,"interventionNames":32},"Benign Liver Disease Group","Participants with benign liver disease and without evidence of hepatocellular carcinoma. A total of 5 participants are planned for this group.",[28],{"label":34,"type":17,"description":35,"interventionNames":36},"Healthy Control Group","Healthy participants without known liver disease or hepatocellular carcinoma. A total of 5 participants are planned for this group.",[28],[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DIAGNOSTIC_TEST","InstaSure™ Non-Invasive Finger-Press Test","Finger-tip skin cell samples are collected non-invasively using a finger-press procedure and tested for HCC-associated CCND1 and CDKN2A\u002FP16 eccDNA signals. Test results are compared with the clinical reference diagnosis to evaluate the ability of the test to distinguish participants with HCC from non-HCC controls.",[30,25,34],[44],"InstaSure™ HCC-Associated CYCLIN D1 & CDKN2A\u002FP16 eccDNA Finger-Press Point-of-Care Screening Test",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":17,"email":50},"Minghui Li, Dr","CONTACT","+8613693259096","wuhm2000@sina.com",{"name":52,"role":48,"phone":53,"phoneExt":17,"email":54},"Lu Zhang, Dr","+8613581975577","zhanglu1218@126.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":17,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":17},"Beijing Ditan Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Minghui Li","Head of Department","100658279","instasure-non-invasive-finger-press-test-for-hepatocellular-carcinoma-100658279",false,"NCT07848750","InstaSure™ Non-Invasive Finger-Press Test for Hepatocellular Carcinoma","InstaSure™ Non-Invasive Finger-Press Point-of-Care Screening Test for Hepatocellular Carcinoma","Inclusion Criteria:\n\nHCC Group:\n\n* Age ≥18 years, with no restriction on sex.\n* Primary hepatocellular carcinoma (HCC) confirmed by histopathology or clinical imaging according to the diagnostic criteria specified in the National Health Commission Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026 Edition).\n\nBenign Liver Disease Group:\n\n\\* Age ≥18 years, with no restriction on sex, with a clinical diagnosis of benign liver disease and hepatocellular carcinoma (HCC) excluded.\n\nHealthy Control Group:\n\n* Age ≥18 years, with no restriction on sex.\n* No history of liver disease, with normal liver function tests and liver ultrasonography.\n\nExclusion Criteria:\n\nHCC Group:\n\n* History or current diagnosis of other pathologically confirmed malignancies, except for malignancies treated with curative intent and without recurrence for more than 5 years.\n* Pregnant or breastfeeding women.\n* Severe systemic diseases, including but not limited to severe cardiac, pulmonary, or renal insufficiency, or uncontrolled acute systemic infection.\n* Receipt of blood transfusion, immunosuppressive therapy, or other interventions that may significantly affect interpretation of the test results within 1 month before enrollment.\n* Conditions affecting standardized fingertip sampling, including but not limited to severe skin lesions, fingertip injury, or inability to complete the standardized sampling procedure.\n* Poor compliance or inability to understand the study, cooperate with study procedures, or complete the study procedures as expected.\n* Any other condition that, in the investigator's judgment, may affect interpretation of the study results or participant safety.\n* Receipt of chemotherapy within 3 months before enrollment, or receipt within 1 month before enrollment of other anticancer treatment that may affect interpretation of nucleic acid signal testing results, including but not limited to targeted therapy, immunotherapy, or tumor radiotherapy.\n\nBenign Liver Disease Group:\n\n* History or current diagnosis of a pathologically confirmed malignancy, except for malignancies treated with curative intent and without recurrence for more than 5 years.\n* Pregnant or breastfeeding women.\n* Severe cardiac, pulmonary, or renal insufficiency, including New York Heart Association (NYHA) functional class III or higher heart failure or chronic kidney disease requiring regular dialysis.\n* Severe infection or active bleeding.\n* Mental or cognitive impairment resulting in inability to understand or sign the informed consent form.\n* Current participation in another interventional clinical trial.\n\nHealthy Control Group:\n\n* History or current diagnosis of a pathologically confirmed malignancy, except for malignancies treated with curative intent and without recurrence for more than 5 years.\n* Pregnant or breastfeeding women.\n* Severe cardiac, pulmonary, or renal insufficiency, including New York Heart Association (NYHA) functional class III or higher heart failure or chronic kidney disease requiring regular dialysis.\n* Severe infection or active bleeding.\n* Mental or cognitive impairment resulting in inability to understand or sign the informed consent form.\n* Current participation in another interventional clinical trial.\n* Recent history of liver disease.",true,"ALL","18 Years",{"count":84,"type":85},40,"ESTIMATED","OBSERVATIONAL","This prospective observational case-control study evaluates the InstaSure™ Non-Invasive Finger-Press Test for hepatocellular carcinoma (HCC). The study plans to enroll 40 participants, including 30 patients with HCC, 5 patients with benign liver disease, and 5 healthy controls. Finger-tip skin cell samples will be collected non-invasively and tested for HCC-associated CCND1 and CDKN2A\u002FP16 eccDNA signals. The primary objective is to preliminarily evaluate the sensitivity and specificity of the test in distinguishing patients with HCC from non-HCC controls. The study will also assess the feasibility of the testing procedure and explore the association between eccDNA signals and clinical characteristics of HCC, providing preliminary data for subsequent larger-scale clinical studies.",[89],"Hepatocellular Carcinoma",[89,91,92,93],"HCC","Liver Cancer","Finger-Press Test","2026-09-27",{"date":96,"type":97},"2026-09-30","ACTUAL",{"date":99,"type":97},"2026-06-30",{"date":101,"type":85},"2026-12-01",{"name":5,"class":6},1]