[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603877":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":32,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"CHA University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Advanced BTC Patients",null,"Description: Patients with histologically or cytologically confirmed advanced biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who are enrolled prospectively across participating centers in Korea.\n\nNumber of Participants: 200 (anticipated)\n\nCohort Type: Single observational cohort",[13],"Genetic: Circulating Tumor DNA (ctDNA) Testing (ctDNA-based Next-Generation Sequencing (NGS))",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"GENETIC","Circulating Tumor DNA (ctDNA) Testing (ctDNA-based Next-Generation Sequencing (NGS))","Peripheral blood will be collected from patients with advanced biliary tract cancer for circulating tumor DNA (ctDNA) testing. Next-generation sequencing (NGS) will be performed to detect clinically relevant genomic alterations, including IDH1 mutations, FGFR2 fusions, ERBB2 amplifications, and MSI-H\u002FdMMR. The ctDNA results will be compared with tissue-based genomic profiling to evaluate concordance and clinical utility.",[9],[21],"Liquid Biopsy, Alpha Liquid 100",[23],{"name":24,"affiliation":25,"role":26},"Hong Jae Chon, MD. PhD","Principal Investigator","PRINCIPAL_INVESTIGATOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","82-31-780-3928","minidoctor@cha.ac.kr",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":10,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Bundang CHA Medical Center","RECRUITING","Seongnam-si","Gyeonggi-do","13496","South Korea",{"type":41,"coordinates":42},"Point",[43,44],127.13778,37.43861,{"lat":44,"lon":43},[47],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},{"type":26,"investigatorFullName":49,"investigatorTitle":25,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Hong Jae Chon","100603877","role-of-ctdna-in-genetic-profiling--outcomes-for-advanced-btc-100603877",false,"NCT07142226","Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC","Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - A Multicenter, Prospective, Observational Epidemiology Study","Inclusion Criteria:\n\n* Patients with histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).\n* Patients who meet one of the following conditions:\n\n  * Patients prior to initiation of first-line systemic chemotherapy, or\n  * Patients previously treated with systemic chemotherapy who can provide a blood sample immediately before starting subsequent therapy.\n* Age ≥ 19 years at the time of enrollment.\n* Willingness to provide a blood sample for ctDNA analysis.\n\nExclusion Criteria:\n\n* Patients who refuse to provide blood samples for ctDNA testing.\n* Patients unable to provide written informed consent.\n* Patients concurrently enrolled in a similar study within the same institution. Prior screening will be performed to prevent duplicate enrollment.","ALL","19 Years",{"count":60,"type":61},200,"ESTIMATED","OBSERVATIONAL","Biliary tract cancer (BTC) is a rare and heterogeneous disease with high incidence and mortality in Korea. Molecular profiling has enabled the identification of actionable alterations such as Isocitrate Dehydrogenase 1 (IDH1) mutations, FGFR2 fusions, ERBB2 amplifications, and dMMR\u002FMSI-H status. However, the utility of tumor tissue-based next-generation sequencing (NGS) is often limited by difficulties in obtaining adequate tissue samples and the lack of in-house sequencing capacity across many hospitals.\n\nCirculating tumor DNA (ctDNA) analysis offers a minimally invasive alternative that can provide rapid and reliable genomic profiling. In a previous study, ctDNA testing showed high concordance with tissue-based genomic profiling for clinically significant alterations, particularly IDH1 mutations, and identified additional mutations not detected in tumor tissue. These findings suggest that ctDNA may expand access to targeted therapies such as ivosidenib .\n\nThis multicenter, prospective, observational epidemiology study, organized by the Korean Cancer Study Group (KCSG) Biliary Tract Cancer Subcommittee, will evaluate the clinical utility of ctDNA-based genomic profiling in patients with advanced BTC. The study will assess concordance between ctDNA and tumor tissue sequencing, describe the prevalence of actionable alterations, and explore the impact of ctDNA testing on treatment decisions and clinical outcomes. By leveraging a nationwide network of BTC specialists, this study seeks to validate ctDNA as a feasible and scalable tool for precision oncology, supporting timely and personalized therapy for patients with BTC.",[65],"Biliary Tract Cancer",[65,67,68,69,70,71],"Biomarker","IDH1 mutation","FGFR2 fusion","Biomarker Analysis","Circulating Tumor DNA (ctDNA)","2026-03-17",{"date":74,"type":75},"2026-03-18","ACTUAL",{"date":77,"type":75},"2025-09-01",{"date":79,"type":61},"2027-01-31",{"name":5,"class":6},1]