[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yingbin Liu, MD, PhD, FACS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100606546","a-cell-free-dna-methylation-blood-based-test-for-biliary-tract-cancers-screening-100606546",false,"NCT07176962","A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening","A Cell-free DNA Methylation Liquid Biopsy for Diagnosis and Management of Biliary Tract Cancers","Inclusion Criteria Internal Training and Validation Cohorts\n\n* BTC patients\n\n  1. Willing to voluntarily participate and able to comply with study procedures; if unable to read or sign, informed consent must be signed by a legally authorized representative (LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed biliary tract carcinoma (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Other gastrointestinal malignancies (to exclude BTC non-specific signals)\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n* Non-cancer participants (benign biliary disease)\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n  4. Pathologically or clinically diagnosed benign biliary diseases, including cholecystitis, cholelithiasis, choledocholithiasis, adenomyomatosis, gallbladder polyps, xanthogranulomatous cholecystitis, or primary sclerosing cholangitis.\n\nExternal Validation Cohorts\n\n* BTC patients\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Imaging findings of malignant biliary stricture or mass, or serum CA19-9 \\> 100 U\u002FmL, highly suspicious for BTC, with planned surgery or biopsy for pathological confirmation.\n  3. Age 18-80 years (inclusive).\n  4. Able to provide required blood samples.\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Healthy volunteers\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n\nExclusion Criteria Training and Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders.\n  7. Known autoimmune diseases.\n  8. Concurrent other malignancies or multiple primary tumors.\n* Non-cancer participants\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders.\n  6. Known autoimmune diseases.\n  7. Clinically significant abnormalities on routine examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).\n\nExternal Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of or ongoing curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders or autoimmune diseases.\n  7. Concurrent other malignancies (including multiple primaries) or known cancer susceptibility gene carriers.\n  8. Pathology confirmed benign disease after biopsy\u002Fsurgery.\n  9. Failure to confirm malignancy by pathology or imaging within 42 days after blood collection, or unclear lesion site\u002Fevidence.\n  10. Special exclusion criteria:\n* Pathology confirmed precancerous lesions.\n* Any local\u002Fregional or systemic anti-tumor therapy (including surgery, radiotherapy, targeted therapy, or immunotherapy) prior to blood collection.\n* Healthy volunteers\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders or autoimmune diseases.\n  6. Clinically significant abnormalities on health examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).",true,"ALL","18 Years","80 Years",{"count":21,"type":22},1800,"ESTIMATED","OBSERVATIONAL","Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.",[26,27,28,29,30,31],"Gall Bladder Cancer","Intrahepatic Cholangiocarcinoma (Icc)","Extrahepatic Cholangiocarcinoma","Hilar Cholangiocarcinoma","Billiary Track Cancer","ctDNA",[33,34,35,30],"ctDNA methylation","Early diagnosis","Liquid biopsy","RECRUITING","2025-09-10",{"date":39,"type":40},"2025-09-16","ACTUAL",{"date":42,"type":40},"2020-01-01",{"date":44,"type":22},"2026-05-01",{"name":46,"class":47},"Yingbin Liu, MD, PhD, FACS","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100596447","mscan-ctdna-methylation-as-prognostic-and-theranostic-tool-for-pancreatic-cancer-100596447","NCT07045571","MSCAN: ctDNA Methylation as Prognostic and Theranostic Tool for Pancreatic Cancer","Methylation Signature of Circulating Tumour DNA as a Prognostic and Theranostic Tool for Managing Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\nPatients meeting all inclusion criteria are eligible to enter this study, including but not limited to:\n\n1. Age range between 18 and 80 years old;\n2. Identification of pancreatic space-occupying lesions through imaging examinations, with a high suspicion of pancreatic malignant tumors and planned for surgical treatment or tissue biopsy for pathological confirmation;\n3. According to RECIST 1.1 evaluation criteria, having at least one measurable lesion (the longest diameter of the target lesion on spiral CT scan ≥10mm);\n4. Ability to provide tumor tissue and blood samples;\n5. Stable vital signs, ECOG score of 0-1;\n6. Liver function with AST and ALT ≤ 5 times the upper limit of normal (ULN), Child-Pugh classification of A or B; white blood cell count \\> 3×10\\^9\u002FL, absolute neutrophil count ≥ 1.5×10\\^9\u002FL; platelets ≥ 75×10\\^9\u002FL; hemoglobin ≥ 90g\u002FL; creatinine clearance rate ≥ 60ml\u002Fmin; total bilirubin ≤ 3 times ULN;\n7. Reproductive-age patients and their spouses willing to adopt contraceptive measures; female patients must undergo a pregnancy test (serum or urine) within 7 days before enrollment with a negative result.\n8. Voluntarily participate in this experimental project, patients with good compliance; if the subject is unable to read or sign, the informed consent form must be signed by a legal representative with the subject's informed consent, and for subjects incapable of expressing consent, the introduction and explanation shall be provided to their legal representative, who will then sign the informed consent form.\n\nExclusion Criteria:\n\nPatients meeting any of the exclusion criteria will not be eligible for inclusion, including but not limited to:\n\n1. Unable to provide tumor tissue and blood samples;\n2. Previously received molecular targeted therapy, immunotherapy, or anti-tumor radiochemotherapy before this study;\n3. History of malignancies other than pancreatic malignancy;\n4. Presence of other severe diseases, including but not limited to uncontrolled congestive heart failure (NYHA class III or IV), unstable angina, poorly controlled arrhythmias, uncontrolled moderate to severe hypertension (SBP \\> 160mmHg or DBP \\> 100mmHg);\n5. Uncontrolled diabetes;\n6. Active infection;\n7. Patients with active autoimmune diseases requiring long-term use of steroids;\n8. Patients who have undergone allogeneic transplantation;\n9. Active psychiatric disorders affecting informed consent and\u002For protocol compliance;\n10. Other severe illnesses deemed inappropriate for participation in this study by investigators.",{"count":57,"type":22},1000,"Developing a characteristic ctDNA methylation panel for pancreatic ductal adenocarcinoma and establishing an intelligent diagnostic and dynamic monitoring model based on ctDNA methylation.",[60,61],"Pancreatic Neoplasm","Pancreas Cancer",[63,35,64,65,34,66],"Pancreatic ductal adenocarcinoma","CtDNA","DNA methylation","Prognosis","2025-06-29",{"date":69,"type":40},"2025-07-01",{"date":71,"type":40},"2022-10-30",{"date":73,"type":22},"2026-07-22",{"name":46,"class":47},""]