[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cholangiocarcinoma-hilar\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cholangiocarcinoma-hilar":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,65,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":39,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100627888","trace-btc-relation-of-biomarkers-and-patients-reported-quality-of-life-to-outcomes-in-patients-with-biliary-tract-cancer-a-real--world-cohort-100627888",false,"NCT07454486","TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort","TRACE-BTC","Inclusion Criteria:\n\n* Histopathologically verified biliary tract cancer (BTC) and\u002For Multidisciplinary Team (MDT) conference decision to define the patient as suffering from BTC.\n* Eligible for curative, adjuvant, or palliative oncological treatment.\n* Age ≥ 18 years.\n* Written and oral consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years of BTC diagnosis, excluding early-stage non-melanoma skin cancer and carcinoma in situ of the cervix.\n* Conditions that prohibit blood sampling.\n* Known or suspected non-compliance.","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","5 Years","OBSERVATIONAL","Purpose of the Study:\n\nBile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed. Even after surgery, the cancer often returns, and chemotherapy only slightly reduces the risk of relapse.\n\nFor patients who cannot have surgery, treatments such as chemotherapy (sometimes combined with immunotherapy) can relieve symptoms and extend life, but their effect is limited. A small number of patients have specific genetic changes in their cancer that can be treated with targeted medicines.\n\nCurrently, doctors cannot predict which patients will benefit from treatment. Standard monitoring methods like CT scans are expensive, inconvenient, and sometimes unreliable because bile ducts are hard to see clearly on scans.\n\nBlood tests that detect cancer DNA in the blood (called circulating tumor DNA or ctDNA) and other biological markers may be a better way to monitor the disease and adjust treatment. These tests could help detect cancer recurrence earlier and determine whether treatment is working. Measuring patients' quality of life and symptoms over time may also help predict treatment benefit and evaluate effectiveness.\n\nThe goal of this study is to:\n\n* Investigate how biomarkers, including ctDNA, can predict disease course, detect relapse, and monitor treatment response.\n* Identify the best way to measure ctDNA in patients with bile duct cancer.\n* Examine whether patients' own reports of quality of life and symptoms can help assess treatment effect and prognosis.\n\nStudy Design and Procedures:\n\nThis is a prospective cohort study focusing on blood biomarkers and patient-reported symptoms and quality of life.\n\nParticipants agree to provide blood samples:\n\n* Before treatment\n* During treatment\n* During follow-up\n\nEach sample involves up to 40 ml of blood, with a maximum of 20 samples per patient.\n\nThe blood will be analyzed for:\n\n* ctDNA and genetic changes\n* Cancer-related markers\n* Inflammation markers\n* Immune system markers\n\nTumor tissue samples will also be examined to compare blood and tissue results. Full genome or exome sequencing will not be performed. Samples will be stored in a research biobank.\n\nFor patients with incurable disease, quality of life and symptom burden will be monitored repeatedly using Danish questionnaires.\n\nParticipants:\n\nThe study will include:\n\n* Up to 100 patients with potentially curable disease\n* Up to 200 patients with incurable disease\n\nTo participate, patients must:\n\n* Have confirmed bile duct cancer\n* Be eligible for curative, additional (adjuvant), or palliative treatment\n* Be over 18 years old\n* Provide written and verbal consent\n\nPatients cannot participate if they:\n\n* Had another cancer within the past 5 years (except early skin cancer or very early cervical cancer)\n* Cannot safely provide blood samples\n* Are unable to cooperate with study procedures\n\nRisks and Inconveniences:\n\nParticipants will have extra blood samples taken, usually during regular hospital visits. Possible side effects include mild soreness or small bruises at the needle site. The extra blood amount (40 ml per sample) is considered medically insignificant.\n\nParticipants will also spend time filling out questionnaires. The number and frequency of questions have been kept as low as possible while still providing meaningful data.\n\nFinancial Information:\n\nExtra costs for blood sampling, laboratory analysis, and data collection will be covered by external research funding managed by Aarhus University Hospital.\n\nThe researchers have no financial interest in the project. Patients will not receive financial compensation for participating.\n\nRecruitment and Consent:\n\nPotential participants are identified during routine clinical care. During a planned meeting with a doctor, patients receive written and verbal information about the study, including its purpose, risks, advantages, and disadvantages.\n\nThe conversation takes place in a calm and private setting. Patients may bring a support person. They have time to ask questions and at least 24 hours to consider participation.\n\nPatients can withdraw their consent at any time without affecting their treatment. Consent must be given before any study-related procedures begin.\n\nPublication of Results:\n\nThe results - whether positive or negative - will be presented at national and international conferences and submitted to peer-reviewed scientific journals.\n\nEthical Considerations:\n\nAll participants receive standard medical treatment. The risks and disadvantages are limited, and participants are unlikely to benefit directly from the study. However, the research may improve how biomarkers and patient-reported outcomes are used to predict prognosis and treatment response, potentially leading to better treatment for future patients with bile duct cancer.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Gall Bladder Cancer","Biliary Tract Cancers (BTC)","Cholangiocarcinoma","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Resectable","Cholangiocarcinoma Metastatic","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Hilar","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma; Liver",[40,29,41,42,43,44,45,46,47,48,49,50,51],"Biliary Tract Neoplasms","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Neoplasms","Circulating Tumor DNA","Liquid Biopsy","Minimal Residual Disease","Biomarkers, Tumor","Observational Study","Biobanking","DNA Methylation","Precision Oncology","NOT_YET_RECRUITING","2026-03-02",{"date":55,"type":56},"2026-03-06","ACTUAL",{"date":58,"type":20},"2026-03-15",{"date":60,"type":20},"2031-12-30",{"name":62,"class":63},"Aarhus University Hospital","OTHER",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100616913","impact-of-vascular-resection-on-survival-and-postoperative-outcomes-in-patients-with-hilar-cholangiocarcinoma-a-retrospective-study-100616913","NCT07311798","Impact of Vascular Resection on Survival and Postoperative Outcomes in Patients With Hilar Cholangiocarcinoma: A Retrospective Study","Inclusion Criteria:\n\n* Patients who underwent surgical treatment at the Department of Hepatobiliary and Pancreatic Surgery of our hospital between January 2010 and December 2024, including those with or without concomitant vascular resection.\n* Pathologically confirmed diagnosis of hilar cholangiocarcinoma after surgery.\n* Complete clinical and follow-up data available for outcome analysis.\n\nExclusion Criteria:\n\n* Patients with distant metastasis or who underwent only palliative or exploratory surgery.\n* Patients diagnosed preoperatively or intraoperatively with other types of biliary malignancies not located at the hilar region.\n* Patients with incomplete medical records or missing key clinical or follow-up data.",{"count":19,"type":20},"Hilar cholangiocarcinoma is a highly aggressive malignancy, and surgical resection remains the only potentially curative treatment. Due to the frequent involvement of major vascular structures, vascular resection is increasingly performed to achieve negative surgical margins; however, its impact on survival and postoperative outcomes remains controversial. This retrospective study aims to evaluate the association between vascular resection and clinical outcomes, including survival and postoperative outcomes, in patients with hilar cholangiocarcinoma undergoing curative-intent surgery.",[35],"2025-12-29",{"date":76,"type":56},"2025-12-31",{"date":78,"type":20},"2025-12",{"date":80,"type":20},"2026-02",{"name":82,"class":63},"Yongjun Chen",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100604441","volume-restricted-resection-for-perihilar-cholangiocarcinoma-100604441","NCT07149558","Volume-Restricted Resection for Perihilar Cholangiocarcinoma","Volume-Restricted Liver Resections for Perihilar Cholangiocarcinoma With Insufficient Future Liver Remnant Volume: A Prospective, Multicenter, Real-World Study","Inclusion Criteria:\n\n* Patients with pathologically confirmed hilar cholangiocarcinoma, or those with a high index of clinical suspicion for hilar bile duct malignancy despite the lack of histological confirmation.\n* Patients who are able to understand and cooperate with this study.\n* Patients who are able to provide and sign the written informed consent form before undergoing any screening procedures related to the study.\n\nExclusion Criteria:\n\n* Patients with preoperatively or intraoperatively confirmed distant metastasis, including peritoneal dissemination, distant lymph node metastasis, hepatic or other organ metastasis.\n* Patients who underwent palliative surgery only.",{"count":19,"type":20},"The goal of this observational study is to learn about the safety and long-term outcomes of volume-restricted liver resection in patients with perihilar cholangiocarcinoma (pCCA) who have an insufficient future liver remnant (FLR). The main question it aims to answer is:\n\nDoes volume-restricted liver resection improve surgical safety and long-term survival compared with standard treatment in pCCA patients with insufficient FLR?\n\nParticipants with insufficient FLR who undergo volume-restricted liver resection or receive non-surgical treatment as part of their routine medical care will be followed for survival, postoperative complications, and other clinical outcomes. Data from patients with sufficient FLR undergoing standard radical resection will also be collected for comparison.",[35],"2025-08-29",{"date":95,"type":56},"2025-09-02",{"date":97,"type":20},"2026-01",{"date":99,"type":20},"2034-01",{"name":82,"class":63}]