[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-cancer-cca\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-cancer-cca":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,94],{"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":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100608807","in-depth-characterisation-of-biliary-strictures-and-hepato-pancreato-biliary-focal-lesions-for-development-of-new-technologies-to-tackle-hepato-pancreato-biliary-cancers-100608807",false,"NCT07206355","In-Depth Characterisation of Biliary Strictures and Hepato-Pancreato-Biliary Focal Lesions for Development of New Technologies to Tackle Hepato-Pancreato-Biliary Cancers","Map HPB","Inclusion Criteria:\n\n* Aged 16 years and over\n* Ability to provide informed consent to participate in the study\n* Patients attending Nottingham University Hospitals NHS Trust (NUH) as part of standard clinical care for either:\n\n  * the diagnosis and treatment of suspected biliary stricture or any focal lesion in the Hepato-Pancreato-Biliary (HPB) tract (clinically \u002F radiologically) including liver or pancreatic lesion or pancreatic cyst\n  * surgical resection treatment of liver, pancreas, or gall bladder including Whipple Procedure (pancreaticoduodenectomy surgery), gall bladder resection (cholecystectomy), hepatic resection\n\nExclusion Criteria: No exclusion criteria","ALL","16 Years",{"count":19,"type":20},160,"ESTIMATED","5 Years","OBSERVATIONAL","Hepato-Pancreato-Biliary (HPB) cancers originating in the liver, bile ducts, pancreas, and gall bladder represent a rising global health challenge, with incidence doubling in the UK over the past decade. Cholangiocarcinoma (CCA) and pancreatic cancer are particularly aggressive, often detected late due to non-specific symptoms and difficulties in sampling or imaging. In the UK, CCA affects around 3,000 people annually, with only 13% surviving 3 years, while pancreatic cancer has a 5-year survival of 8.3%. Diagnosis is complicated by the anatomical narrowness of the bile duct and the similarity between malignant and benign strictures. Standard imaging often cannot distinguish between inflammation and cancer, while tissue sampling is challenging, paucicellular, and limited in sensitivity, necessitating repeated biopsies. Yet, accurate characterisation is critical as NICE now recommends targeted therapies (FGFR2, NTRK, MSI-H\u002FdMMR, IDH1 mutations) that require molecular profiling.\n\nBoth CCA and PDAC display high heterogeneity, further complicating treatment. Emerging approaches such as Raman spectroscopy can map malignant tissues by detecting vibrational energy shifts, but require further validation due to weak signals. For focal or cystic HPB lesions not well visualised by conventional imaging, novel modalities like ultra-thin endoscopes with scattering\u002Fabsorption imaging are being developed for improved early diagnosis.\n\nManagement of biliary obstruction frequently involves stenting to restore bile flow, essential for palliation and pre-treatment optimization. However, stent failure from tumour ingrowth, displacement, or erosion remains common, and evidence for best stent use is limited. Novel approaches, including drug-eluting coatings and nanoparticle-mediated wireless treatment delivery, are being investigated.\n\nTo overcome diagnostic and therapeutic barriers, flexible snake-like robotic systems with navigation, sampling, spectroscopy, and treatment capabilities are being developed. These devices, alongside ultra-thin endoscopes and integrated Raman spectroscopy, aim to characterise strictures, generate 3D imaging in ex-vivo HPB tissue, and permit targeted ablation. Parallel work will explore molecular and fluid-based biomarkers (blood, bile, cyst fluid) to support minimally invasive diagnosis and monitoring.\n\nThrough integration of engineering, molecular diagnostics, and device innovation, this transdisciplinary research programme (UKRI and MRC funded) seeks to transform early detection, accurate diagnosis, and novel treatment of HPB cancers, thereby improving outcomes in CCA, pancreatic malignancy, and other clinically similar biliary disorders.\n\nAim:\n\nTo provide a detailed understanding of the characteristics (including clinical and molecular) of liver and pancreatic biliary focal lesions (inflammatory and cancerous) and create a bioresource of liver, pancreas, gallbladder and biliary tract associated tissue and fluids (biopsies, brushings, resected tissues, bile and cyst fluid and blood samples) in order to develop innovative tools for accurate diagnosis and treatment.\n\nStudy Configuration: Prospective Longitudinal Cohort study Setting: Secondary care centre, Nottingham University Hospitals NHS Trust. (NUH).\n\nCo-ordinated by the NIHR Nottingham Biomedical Research Centre Description of interventions: This is an observational study involving collecting tissue or body fluids (such as bile or pancreatic cyst fluid) during clinical care in addition to collection of blood samples (for DNA, serum and plasma) and data collection.\n\nSurplus tissue residual to the requirements for standard care will be stored and used. Additional tissue samples and body fluid samples collected for research at time of clinical investigations will not be increasing the risk of the clinical procedure.\n\nBlood samples will be collected from patients at the time of enrolment in the study. These may be collected before and\u002F or after diagnosis is secured.\n\nDuration of study: Overall duration: 60 months Outcome measures: - To report the proportion of patients where adequate tissue could be retrieved from HPB biopsy to come to definitive diagnosis using standard of care.\n\n* To report the proportion of patients where adequate tissue could be retrieved from biopsy to perform molecular characterisation of HPB samples, beyond standard cyto\u002Fhistology, using advanced optical-spatial technologies currently under development.\n* To report the proportion of patients where definitive diagnosis of mucinous cystic neoplasm could be made in patients with pancreatic cyst using standard care\n* To report the proportion of patients where molecular characterisation beyond standard cyto\u002Fhistology could be made in patients with pancreatic cyst using exploratory new technologies under development through ex-vivo experiments\n* To report the correlation between Raman Spectroscopy and standard cyto\u002Fhistology for identification of cancer in HPB samples",[25,26,27,28,29,30,31],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Cholangiocarcinoma","Cholangiocarcinoma Cancer","Cholangio Carcinoma","Pancreatic Cancer","Pancreatic Cyst",[33,30,31,34,25,27],"biliary tract cancer","Pancreatic lesions","RECRUITING","2026-04-28",{"date":38,"type":39},"2026-04-29","ACTUAL",{"date":41,"type":39},"2026-01-25",{"date":43,"type":20},"2030-09-30",{"name":45,"class":46},"University of Nottingham","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":71,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":47},"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","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.","18 Years",{"count":57,"type":20},300,"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.",[25,26,60,61,27,62,63,64,65,66,67,68,69,70],"Gall Bladder Cancer","Biliary Tract Cancers (BTC)","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Resectable","Cholangiocarcinoma Metastatic","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Hilar","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma; Liver",[72,27,73,74,75,76,77,78,79,80,81,82,83],"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":87,"type":39},"2026-03-06",{"date":89,"type":20},"2026-03-15",{"date":91,"type":20},"2031-12-30",{"name":93,"class":46},"Aarhus University Hospital",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":47},"100603363","phase-2-a-single-arm-multicenter-exploratory-study-of-adebrelimab-combined-with-apatinib-and-systemic-chemotherapy-for-initially-unresectable-biliary-tract-cancer-100603363","NCT07135544","A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer","Inclusion Criteria:\n\n\\- 1. Pathological or histological diagnosis of malignant tumor of the biliary tract; 2. Patients who are classified as TxNx and TxNxM1 according to the UICC\u002FAJCC TNM staging system (9th edition, 2024), and who, based on the judgment of the research team, meet the criteria for newly diagnosed incurable cases or are not suitable for surgery; 3. Age: 18-80 years old; 4. Expected survival period \\> 3 months; 5. Both genders are eligible; 6. ECOG PS score of 0 or 1; 7. No severe complications, such as hypertension, coronary heart disease, and history of mental illness, no severe allergy history; non-pregnant and non-lactating; 8. The patient's organ and hematological system functions meet the following requirements:\n\n1. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n2. Platelet count ≥ 75 × 10\\^9\u002FL;\n3. Hemoglobin ≥ 90 g\u002FL;\n4. Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN);\n5. Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN;\n6. Albumin ≥ 3 g\u002FdL\n7. Creatinine ≤ 1.5 x ULN 9. Patients can understand and sign the informed consent form to participate in the trial study; good compliance.\n\n10\\. Newly diagnosed patients, who have not undergone any local or systemic treatment for the tumor in the past and have undergone radical resection surgery for biliary cancer, and whose disease recurs 2 years after the surgery can be included; 11. Patients with potential fertility should use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and within 1 month after the end of the study treatment; and the serum or urine HCG test must be negative within 72 hours before the study enrollment, and must be non-lactating.\n\nExclusion Criteria:\n\n* 1\\. Patients who received immune checkpoint inhibitors before enrollment, or those who directly received another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, CD137); 2. Patients who used any other investigational drug within 4 weeks before enrollment; 3. Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); children with asthma who have completely recovered after adulthood and do not require any intervention can be included, but patients requiring bronchodilator drug intervention cannot be included; 4. Congenital or acquired immune deficiencies, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA \\> 500 IU\u002Fml), hepatitis C (positive hepatitis C antibody, HCV-RNA above the detection limit of the analytical method), or co-infection of hepatitis B and hepatitis C; 5. Serious infections occurred within 4 weeks before the first administration (such as intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever \\> 38.5°C during screening or before the first administration; 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Having an uncontrolled mental disorder; 8. Concurrently having severe and\u002For uncontrollable diseases that may affect the participation in the study, such as unstable angina pectoris, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, poorly controlled diabetes, excessive activity, uncontrollable infection after insufficient biliary drainage (such as tumor blocking the bile duct); 9. Other cancers that occurred in the past (within the past 5 years) or simultaneously, excluding non-melanoma skin cancer and carcinoma in situ; 10. History of allergy or hypersensitivity to any study drug or any monoclonal antibody; 11. Unable or unwilling to sign the informed consent form.","80 Years",{"count":102,"type":20},37,"INTERVENTIONAL",[105],"PHASE2","This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigated.",[108,26],"Biliary Tract Cancer",[110],"Adebrelimab","2025-08-20",{"date":113,"type":39},"2025-08-22",{"date":115,"type":39},"2025-08-14",{"date":117,"type":20},"2028-12-30",{"name":119,"class":46},"Yongjun Chen"]