[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fragmentomics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fragmentomics":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100623636","noninvasive-detection-of-lung-nodule-malignancy-using-cfdna-fragmentomics-100623636",false,"NCT07399210","Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics","A Prospective Clinical Study Evaluating the Noninvasive Use of Circulating Cell-Free DNA Fragmentomics to Differentiate Benign and Malignant Lung Nodules, With Emphasis on Small Nodules.","SHC2408","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Positive for lung nodules on low-dose spiral CT (LDCT) meeting one of the following criteria:\n\nSolid or part-solid nodules ≥ 5 mm and ≤ 20 mm; Pure ground-glass nodules ≥ 8 mm and ≤ 30 mm; In cases of multiple nodules, the largest nodule (by maximum diameter) must meet these criteria;\n\n* Participants whose lung nodule status (benign or malignant) can be clinically confirmed;\n* No cancer-directed therapy (e.g., chemotherapy, radiotherapy, immunotherapy, cell therapy) within the past 3 months;\n* Able to provide a 5 mL peripheral blood sample prior to any treatment;\n* Voluntary signing of informed consent after full explanation of the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding;\n* Current or past diagnosis (within the past 5 years) of malignant tumors (excluding patients with early-stage lung cancer who have undergone surgery but still have multiple evaluable nodules), or with severe heart disease, serious liver or kidney disorders, or significant bone marrow hematopoietic dysfunction;\n* History of organ transplantation or blood transfusion within the past 3 months;\n* History of seropositivity for human immunodeficiency virus (HIV);\n* Any other condition deemed inappropriate for study participation by the investigators.","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","1 Month","OBSERVATIONAL","The goal of this observational study is to learn if cfDNA fragmentomics can noninvasively diagnose whether lung nodules are benign or malignant in adults with imaging-detected lung nodules.",[26,27],"Lung Cancer (Diagnosis)","Fragmentomics",[27,29,30,31,32],"Lung Cancer(Diagnosis)","cfDNA","Small Nodule","Non-invasive","RECRUITING","2026-02-08",{"date":36,"type":37},"2026-02-10","ACTUAL",{"date":39,"type":37},"2024-08-21",{"date":41,"type":21},"2026-08-21",{"name":43,"class":44},"Baohui Han","OTHER"]