[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604561":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":43,"studyPopulation":44,"armGroups":45,"interventions":51,"overallOfficials":58,"centralContacts":63,"locations":71,"responsibleParty":89,"collaborators":90,"id":94,"slug":40,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":40,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":40,"enrollmentInfo":102,"targetDuration":40,"studyType":105,"phases":40,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":74,"whyStopped":40,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"CHA University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Detection of Actionable Genomic Alterations by ctDNA Profiling","Frequency of targetable genetic alterations, especially FGFR2 fusion, detected in ctDNA from patients with advanced biliary tract cancer.","Baseline (within 30 days prior to initiation of systemic therapy or prior to subsequent treatment)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Frequency of Specific Genomic Alterations by ctDNA Analysis","Assessment of the frequency of specific genetic alterations (e.g., FGFR2 fusion) identified by ctDNA in Korean patients with advanced biliary tract cancer.","Up to 24 months",{"measure":19,"description":20,"timeFrame":17},"Proportion of Patients Receiving Targeted Therapy Based on ctDNA Findings","Percentage of patients who received targeted therapies (including pemigatinib for FGFR2 fusion) according to ctDNA-based genomic profiling results.",[22,25,28,31,35],{"measure":23,"description":24,"timeFrame":17},"Association of ctDNA Variant Allele Frequency With Clinical Prognosis","Correlation of maximum variant allele frequency (max VAF) in ctDNA with survival outcomes in advanced biliary tract cancer patients.",{"measure":26,"description":27,"timeFrame":17},"Clinical Outcomes in Patients Treated With Targeted Therapy","Proportion of patients achieving complete response, partial response, or stable disease based on RECIST v1.1 criteria among those treated with pemigatinib or other targeted therapies.",{"measure":29,"description":30,"timeFrame":17},"Survival Outcomes in Patients Receiving Targeted Therapy","Progression-free survival (PFS) and overall survival (OS) of patients treated with pemigatinib or other targeted therapies according to ctDNA findings.",{"measure":32,"description":33,"timeFrame":34},"Resistance Mechanisms and Clonal Evolution Identified by Serial ctDNA Analysis","Exploration of acquired resistance mechanisms and clonal evolution through repeat ctDNA analysis in patients treated with FGFR2 inhibitors such as pemigatinib.","At progression or up to 24 months",{"measure":36,"description":37,"timeFrame":38},"Concordance of Genomic Alterations Between ctDNA and Tissue next-generation sequencing (NGS)","Assessment of concordance between genomic alterations, including FGFR2 fusion and other actionable mutations, identified by ctDNA and those detected by tissue next-generation sequencing when available.","Baseline and up to 24 months",{"allocation":40,"interventionModel":40,"interventionModelDescription":40,"primaryPurpose":40,"observationalModel":41,"timePerspective":42,"maskingInfo":40},null,"COHORT","PROSPECTIVE","Biliary tract cancer (BTC) is a heterogeneous and aggressive malignancy with poor prognosis, especially in advanced or metastatic stages where surgical resection is not feasible. The current standard first-line therapy with gemcitabine and cisplatin provides limited survival benefit, with median overall survival around 11-12 months. Targeted therapies, such as FGFR inhibitors for FGFR2 fusions and IDH1 inhibitors, as well as immune checkpoint inhibitors, have improved outcomes in subsets of patients. However, tumor tissue acquisition remains challenging in BTC, limiting the ability to perform comprehensive genomic profiling.\n\nCirculating tumor DNA (ctDNA) has emerged as a promising biomarker for molecular profiling, treatment monitoring, and prognosis assessment. Prior studies demonstrated acceptable concordance between ctDNA-based and tissue-based next-generation sequencing, particularly for FGFR2 fusions, and highlighted the potential of ctDNA in identifying additional genomic alterations not detected in tissue samples.\n\nThis prospective study will enroll 100 Korean patients with advanced or metastatic BTC from 11 hospitals. Approximately two-thirds of patients will provide blood samples prior to first-line systemic therapy, while one-third will provide samples before subsequent therapy. Additional blood draws will be performed at progression in patients harboring FGFR2 fusion, IDH1 mutation, or HER2 amplification. Collected samples will be analyzed by a central laboratory (SCL Healthcare, a precision medicine service provider specializing in biomarker-based diagnostics).\n\nThe primary objective is to evaluate the frequency of actionable genomic alterations, especially FGFR2 fusions, detected by ctDNA in advanced BTC patients. Secondary objectives include:\n\n* Assessing the concordance between ctDNA and tissue genomic profiling\n* Evaluating the proportion of patients who received targeted therapy based on ctDNA results (e.g., pemigatinib \\[Pemazyre®\\])\n* Exploring associations between ctDNA maximum variant allele frequency (max VAF) and survival outcomes\n* Identifying potential resistance mechanisms and clonal evolution during targeted therapy\n\nThis study is expected to provide robust evidence for the clinical utility of ctDNA in BTC and contribute to the establishment of precision medicine approaches, potentially supporting future guideline development and regulatory approval of ctDNA assays in Korea and globally.","Korean patients with advanced or metastatic biliary tract cancer (intrahepatic, extrahepatic, or gallbladder carcinoma), enrolled for ctDNA-based genetic profiling prior to systemic therapy or before subsequent treatment initiation.",[46],{"label":47,"type":40,"description":48,"interventionNames":49},"Advanced Biliary Tract Cancer Patients","Patients with histologically confirmed advanced or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer). Participants will provide blood samples for circulating tumor DNA (ctDNA) analysis before systemic therapy or prior to subsequent treatment.",[50],"Other: Blood Sampling for ctDNA Analysis",[52],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Blood Sampling for ctDNA Analysis","Approximately 20 mL of peripheral blood will be collected from patients with advanced biliary tract cancer. Samples will be obtained prior to systemic therapy initiation (in about two-thirds of patients) or prior to subsequent therapy (in about one-third of patients). Additional blood draws may be performed at progression in patients with FGFR2 fusion, IDH1 mutation, or HER2 amplification. Collected samples will be centrally analyzed for genomic alterations using ctDNA profiling.",[47],[57],"Liquid Biopsy; Plasma Collection",[59],{"name":60,"affiliation":61,"role":62},"Hong Jae Chon","Principal Investigator","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":40,"email":68},"Hong Jae Chon, MD. PhD","CONTACT","82-31-780-3928","minidoctor@cha.ac.kr",{"name":65,"role":66,"phone":67,"phoneExt":40,"email":70},"hongjaechon@gmail.com",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":40,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"CHA Bundang Medical Center","RECRUITING","Seongnam-si","Gyeonggi-do","13496","South Korea",{"type":80,"coordinates":81},"Point",[82,83],127.13778,37.43861,{"lat":83,"lon":82},[86,88],{"name":65,"role":66,"phone":87,"phoneExt":40,"email":68},"82-31-780-3430",{"name":60,"role":62,"phone":40,"phoneExt":40,"email":40},{"type":62,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},[91],{"name":92,"class":93},"Handok Inc.","INDUSTRY","100604561",false,"NCT07151118","ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer","Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - Prospective, Observational, Epidemiology Study","Inclusion Criteria:\n\n* Histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma)\n* Patients meeting one of the following conditions:\n\n  * Prior to initiation of first-line systemic therapy\n  * Patients who previously received systemic therapy and are able to provide a blood sample prior to initiation of subsequent therapy\n* Age ≥ 19 years at the time of enrollment\n* Willingness and ability to provide blood samples for ctDNA analysis\n\nExclusion Criteria:\n\n* Refusal to provide blood samples for ctDNA testing\n* Inability to provide written informed consent","ALL","19 Years",{"count":103,"type":104},100,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, observational study aims to evaluate the role of circulating tumor DNA (ctDNA) in advanced or metastatic biliary tract cancer (BTC) patients in Korea. Tissue-based genomic profiling is often limited due to the anatomical challenges of tumor biopsy and insufficient DNA quality. ctDNA analysis offers a minimally invasive alternative for identifying actionable genetic alterations, including Fibroblast Growth Factor Receptor 2 (FGFR2) fusions, Isocitrate Dehydrogenase 1 (IDH1) mutations, and Human Epidermal Growth Factor Receptor 2 (HER2) amplifications. The study will recruit 100 patients across 11 institutions and assess the concordance between ctDNA and tissue genomic profiling, as well as the clinical relevance of ctDNA in predicting treatment outcomes and prognosis.",[108],"Biliary Tract Cancer",[108,110,111,112,113,114],"Biomarker","IDH1 mutation","FGFR2 fusion","Circulating Tumor DNA (ctDNA)","Biomarker Analysis","2026-03-17",{"date":117,"type":118},"2026-03-18","ACTUAL",{"date":120,"type":118},"2025-09-01",{"date":122,"type":104},"2027-08-31",{"name":5,"class":6},1]