[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"suspected-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:suspected-lung-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100643349","ctdna-mutations-and-methylation-status-for-early-detection-of-lung-cancer-in-patients-with-suspicious-lung-nodules-100643349",false,"NCT07615556","ctDNA Mutations and Methylation Status for Early Detection of Lung Cancer in Patients With Suspicious Lung Nodules","Circulating Tumor DNA Mutations and Methylation Status as Biomarkers for Early Detection of Lung Cancer in Patients With Suspicious Lung Nodules","Inclusion Criteria:\n\n1. Age 45 - 80 years;\n2. Suspicious lung nodules (\\> 0.5 - 30mm in longest diameter, non-calcified) found within the past six months, or if PET scan has been done before, the specific uptake value (SUV) should be more than 1\n\nExclusion Criteria:\n\n1. Age \\\u003C 45 or \\> 80;\n2. Lung nodules of \\\u003C 0.5 cm in longest diameter, or with calcification seen in imaging;\n3. Known lung cancer or lung metastasis before, or history of extra-pulmonary cancer;\n4. Active tuberculosis;\n5. Clinical unstable conditions including untreated ischemic heart disease or arrhythmia, uncontrolled airway disease;\n6. Unwillingness to undergo invasive investigation like bronchoscopy;\n7. Unable to provide informed written consent.","ALL","45 Years","80 Years",{"count":20,"type":21},200,"ESTIMATED","2 Years","OBSERVATIONAL","Lung Cancer is common in Asia and is different from lung cancer from Western countries in terms of lung cancer epidemiology and management. Lung cancer can be detected early but most early-stage lung cancer appear as lung nodules with suspicious features on imaging. Workup and surveillance for subjects with suspicious lung nodule is a clinical problem. There is no consensus and clinical practice usually varies with local epidemiology of lung diseases namely the local clinical characteristics especially with lung cancer and pulmonary tuberculosis. The clinical challenge is to address whether pulmonary nodules identified on CT screening carry short- and long-term risk for lung cancer. The main objective of this study is to test the improvement of efficiency of diagnostic evaluation with clinical parameters and ctDNA mutation\u002Fmethylation profiling for artificial intelligence modeling of for early detection of lung cancer in subjects with suspicious lung nodules. The hypothesis is that ctDNA mutation and methylation will enhance early detection of lung cancer in patients with suspicious lung nodules. This is a longitudinal cohort study. A total of 200 subjects (100 from Hong Kong and 100 from Vietnam) with suspicious lung nodules on CT Thorax will be recruited. Blood samples will be collected at recruitment and subsequent 6 months follow up. ctDNA mutations and methylation with SPOTMAS Lung assays would be performed at baseline and at 6 months follow-up. The CT scan where the suspicious lung nodules were identified, will be used as baseline scan for recruitment. Recruited subjects will be arranged with a non-contrast LDCT scans at 6 months follow-up. The primary outcome measure of the study is the detection of ctDNA mutation and methylation in correlation with diagnosis of lung cancer or persistence of suspicious lung nodules. The secondary outcome measures of the study are the Sensitivity and specificity of clinical biomarkers in correctly identifying malignant lung nodule, i.e., lung cancer.",[26,27,28],"Lung Nodules","Lung Cancer Screening","Suspected Lung Cancer",[30,31,32,33],"ctDNA mutation","Methylation status","Early detection of lung cancer","Suspicious lung nodules","NOT_YET_RECRUITING","2026-06-04",{"date":37,"type":38},"2026-06-08","ACTUAL",{"date":40,"type":21},"2026-06",{"date":42,"type":21},"2028-12",{"name":44,"class":45},"The University of Hong Kong","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":46},"100640926","preoperative-decision-making-in-patients-with-pulmonary-nodules-suspected-of-lung-cancer-100640926","NCT07590596","Preoperative Decision-Making in Patients With Pulmonary Nodules Suspected of Lung Cancer","Preoperative Decision-Making Characteristics and Associated Mechanisms in Patients With Pulmonary Nodules Suspected of Lung Cancer","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Adult patients with pulmonary nodules that are highly suspected of malignancy based on clinical and radiological assessment.\n3. No definite pathological diagnosis of lung cancer before enrollment.\n4. Patients who are facing preoperative clinical decision-making with more than one reasonable management option, such as surgery, additional diagnostic evaluation, or follow-up.\n5. Able to understand the study procedures and complete the study questionnaires.\n6. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients without a real clinical decision-making choice regarding the management of the pulmonary nodule.\n2. Patients with severe cognitive impairment or a history of severe psychiatric disease that would interfere with valid questionnaire completion.\n3. Patients who are unable to communicate effectively with the study staff.\n4. Patients who decline to participate or are unable to provide written informed consent.","18 Years",{"count":20,"type":21},"Patients with pulmonary nodules that are highly suspected to be lung cancer often need to make important treatment decisions before a definite pathological diagnosis is available. These decisions may include whether to undergo surgery, whether to continue follow-up, whether to have further diagnostic tests, and how to understand the potential benefits and risks of different management options.\n\nThis prospective observational study aims to describe the preoperative decision-making status of adult patients with pulmonary nodules suspected of lung cancer. The study will assess patients' decision self-efficacy, decisional conflict, shared decision-making experience, and decision regret using standardized questionnaires. It will also explore factors associated with better or worse decision quality, such as demographic characteristics, clinical information, health literacy, doctor-patient communication, family involvement, and emotional status.\n\nNo treatment or intervention will be assigned by the study. Participants will receive routine clinical care, and study data will be collected mainly through questionnaires before surgery or during the preoperative period. The findings may help clinicians identify patients who need additional decision support and improve communication during preoperative decision-making for suspected lung cancer.",[58,28,59],"Pulmonary Nodule","Preoperative Decision-Making",[61,62,63,64,65,58,28,66,59,67],"Shared Decision Making","Decisional Conflict","Decision Self-Efficacy","Decision Quality","Decision Regret","Thoracic Surgery","Patient-Centered Care","2026-05-14",{"date":70,"type":38},"2026-05-18",{"date":72,"type":21},"2026-05",{"date":74,"type":21},"2027-07-31",{"name":76,"class":45},"Sichuan Cancer Hospital and Research Institute"]