[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589934":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":63,"collaborators":10,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HCC patients at baseline",null,"At baseline, patients will undergo history-taking, clinical examination, laboratory investigations, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, Triphasic CT abdomen with contrast or MRI (for evaluation of tumor site, size and number), and Fibroscan examination",[13],"Radiation: fibroscan",{"label":15,"type":10,"description":16,"interventionNames":17},"HCC patients 6 months post immunotherapy","All patients will be followed up after 6 months with clinic visits including laboratory testing, evaluation of treatment-related side effects, imaging studies, and fibroscan examination.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"RADIATION","fibroscan","Liver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography).",[15,9],[25],{"name":26,"affiliation":27,"role":28},"Nabila A Elgazzar, MD","Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Rania M Elkafoury, MD","CONTACT","+201004672358","rania.elkafoury@med.tanta.edu.eg",{"name":26,"role":32,"phone":36,"phoneExt":10,"email":37},"00201288585733","nabilaelgazzar@med.tanta.edu.eg",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Tanta University Hospitals","RECRUITING","Tanta","Gharbyea","31516","Egypt","EG",{"type":48,"coordinates":49},"Point",[50,51],31.00192,30.78847,{"lat":51,"lon":50},[54,58,60,61],{"name":55,"role":32,"phone":56,"phoneExt":10,"email":57},"Dina H Ziada, MD, head of department","00201117109990","dina.ziada@med.tanta.edu.eg",{"name":31,"role":59,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":26,"role":28,"phone":10,"phoneExt":10,"email":10},{"name":62,"role":59,"phone":10,"phoneExt":10,"email":10},"Madonna M Fahmy, MD",{"type":28,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Rania Mamdouh Elkafoury","lecturer of Tropical medicine","100589934","fibroscan-evaluating-immunotherapy-response-in-hepatocellular-carcinoma-100589934",false,"NCT06960863","Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma","Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.","Inclusion Criteria:\n\n* Patients with confirmed advanced HCC (Diagnosed by two imaging modalities or liver biopsy) eligible for immunotherapy.\n* Patients with preserved liver function (compensated Child-Pugh A if there is underlying cirrhosis).\n* Patients with performance status ≤2 at staging work-up.\n* absence of high-risk stigmata for bleeding on upper endoscopy, e.g. properly treated oesophageal varices and no history of variceal bleeding, in order to minimise bleeding risk.\n\nExclusion Criteria:\n\n* Prior locoregional therapy or liver transplantation.\n* Child-Pugh class C patients.\n* Patients with performance status \\>2 at staging work-up.\n* Vascular disorders, arterial hypertension, and risk of variceal bleeding.\n* Severe autoimmune disorders.\n* Patients who lost follow-up.\n* Pregnant or breastfeeding women.\n* Unwilling to participate in our study.","ALL","18 Years",{"count":76,"type":77},80,"ESTIMATED","OBSERVATIONAL","The goal of this prospective cohort study is to evaluate the role of transient elastography (Fibroscan) in predicting the response of immunotherapy in advanced Hepatocellular carcinoma (HCC) patients.\n\nResearchers will predict the response to 6 months of HCC immunotherapy regarding improvement of the degree of liver fibrosis, development of liver decompensation, complications, survival, and mortality.\n\nParticipants will undergo history-taking, clinical examination, laboratory investigations, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, Triphasic CT abdomen with contrast or MRI (for evaluation of tumor site, size and number), and Fibroscan examination at baseline and follow-up after 6 months.",[81],"Hepato Cellular Carcinoma (HCC)",[21,83,84,85],"immunotherapy","liver stiffness","hepatocellular carcinoma","2025-04-29",{"date":88,"type":89},"2025-05-07","ACTUAL",{"date":91,"type":89},"2025-01-26",{"date":93,"type":77},"2026-01-31",{"name":5,"class":6},1]