[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497103":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":7,"responsibleParty":19,"collaborators":7,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":7,"eligibilityCriteria":27,"healthyVolunteers":23,"sex":28,"minAge":29,"maxAge":7,"enrollmentInfo":30,"targetDuration":33,"studyType":34,"phases":7,"briefSummary":35,"conditions":36,"keywords":41,"overallStatus":43,"whyStopped":7,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":7},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Chia-Hsien Cheng","Employee","PRINCIPAL_INVESTIGATOR",[14],{"name":10,"role":15,"phone":16,"phoneExt":17,"email":18},"CONTACT","886-223123456","67141","jasoncheng@ntu.edu.tw",{"type":20,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100497103","a-novel-biomarker-for-response-and-prognosis-of-hbv-related-hepatocellular-carcinoma-100497103",false,"NCT05752890","A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma","Developing a Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma Treated With Radiotherapy: Personalized Cell-free Virus-host Chimera DNA","Inclusion Criteria:\n\n1. Patients diagnosed with HCC by dynamic image criteria and\u002For biopsy\n2. HBsAg (+)\n3. Child-Turcotte-Pugh (CTP) class A-B liver function\n4. Radiotherapy to liver tumor as the main treatment\n\nExclusion Criteria:\n\n1. Child-Turcotte-Pugh (CTP) class C liver functiECOG performance status score \\>2\n2. Has had prior radiotherapy to the proposed treatment field.\n3. \\\u003C 18 years old","ALL","18 Years",{"count":31,"type":32},95,"ESTIMATED","3 Months","OBSERVATIONAL","The investigators will first use our previously collected serum samples and surgical\u002Fbiopsied tissues from HBV-related HCC patients undergoing radiotherapy. The consistency of junctional clones by Capture NGS needs to be tested between both pre- and post-RT serums, and serial changes in copy numbers of vh-DNA by ddPCR are quantified in the representative cases. The same junction clones from pre-post-RT serums and surgical tissues will be confirmed and the copy number changes of vh-DNA be correlated with RT response and disease-control status.\n\nThe investigators plan to identify HBV integrations by Capture NGS and quantify the specific vh-DNA by ddPCR as personalized biomarkers from the same-patient serum samples. The investigators will further correlate clinical response and recurrence\u002Fmetastasis with serial changes of vh-DNA copy numbers. The investigators have been prospectively collecting plasma samples from HBV-related HCC patients before\u002Fafter RT, at 1, 4, 7 months, and at recurrence\u002Fmetastasis. The investigators plan to confirm the viable role of pre-\u002Fpost-RT changes of plasma vh-DNA copies of the same junction clone in post-RT response and prognosis. Moreover, The investigators will explore the recurrent\u002Fmetastatic tumors arising from the original or a de novo one by identifying their clonality with HBV integration patterns. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support the consolidative use of personalized vh-DNA for earlier evaluating treatment response after RT, for post-RT disease monitoring, and for differentiating clonality at recurrence to design future clinical trial on combinational treatment.",[37,38,39,40],"Hepatocellular Carcinoma","Hepatitis b Virus","Radiotherapy","Biomarker",[37,38,39,42,40],"Chimera DNA","NOT_YET_RECRUITING","2023-02-21",{"date":46,"type":47},"2023-03-03","ACTUAL",{"date":49,"type":32},"2023-03-01",{"date":51,"type":32},"2031-01-31",{"name":5,"class":6}]