[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-nodules-solitary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-nodules-solitary":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100555943","differentiation-of-benign-and-malignant-pulmonary-nodules-by-volatile-organic-compounds-in-human-exhaled-breath-100555943",false,"NCT06518655","Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath","Exploratory Study on the Identification of Benign and Malignant Pulmonary Nodules Using Volatile Organic Compounds in Human Exhaled Breath","Inclusion Criteria:\n\n* 18-80 years old;\n* Pulmonary nodules were detected through low-dose spiral CT, chest CT conventional scan, or high-resolution thin-layer CT examination, with a maximum diameter of 5-30 mm, including solid nodules and ground glass nodules;\n* Patients require pulmonary nodule resection to define the type of nodule pathology;\n* The Patients have not yet used any drugs for tumor treatment;\n* Patients and\u002For family members are able to understand the research protocol and are willing to participate in this study, providing written informed consent.\n\nExclusion Criteria:\n\n* The maximum diameter of pulmonary nodules is greater than 30 mm;\n* Patients are unable to determine the pathological diagnosis of pulmonary nodules after surgical resection or biopsy;\n* Patients with recurrent lung cancer;\n* Patients who have undergone lung transplantation or lobectomy;\n* Individuals who currently or have a history of malignant tumors;\n* Patients in the acute phase of inflammation or in need of intensive care in the above selected disease groups;\n* Individuals with severe liver and kidney dysfunction;\n* Mental illness patients (such as severe dementia, schizophrenia, severe depression, manic depressive psychosis, etc.);\n* Confirmed HIV patients;\n* Pregnant or lactating women;\n* Patients or family members are unable to understand the conditions and objectives of this study.\n* The patient is unwilling or unable to personally sign the informed consent form.",true,"ALL","18 Years","80 Years",{"count":21,"type":22},3000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) markers. This model aims to accurately differentiate benign from malignant nodules in individuals harboring pulmonary nodules. The primary objectives it strives to accomplish are:\n\n1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in distinguishing benign and malignant pulmonary nodules.\n2. To evaluate the diagnostic effectiveness of an AI model that employs exhaled breath VOC biomakers to identify specific types of malignant nodules, including lung adenocarcinoma, lung squamous cell carcinoma, and small cell lung cancer.\n3. To explore and identify key characteristic VOCs combinations that are associated with EGFR site mutations in malignant nodules, further modeling and evaluating the classification performance.\n\nBy utilizing this comprehensive approach, the study hopes to contribute significantly to early detection and accurate classification of pulmonary nodules, ultimately leading to improved patient care and treatment outcomes.",[26,27,28],"Pulmonary Nodules, Multiple","Pulmonary Nodules, Solitary","Lung Cancer",[30,28,31,32],"Pulmonary Nodules","Volatile Organic Compounds","Human Exhaled Breath","RECRUITING","2025-12-18",{"date":36,"type":37},"2025-12-24","ACTUAL",{"date":39,"type":37},"2024-06-30",{"date":41,"type":22},"2027-06-30",{"name":43,"class":44},"ChromX Health","INDUSTRY",15,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100607167","early-phase-1-an-exploratory-clinical-study-on-the-safety-and-efficacy-of-autologous-nk-cells-in-the-treatment-of-pulmonary-nodules-100607167","NCT07185035","An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules","Inclusion Criteria:\n\n1. Subjects voluntarily sign the informed consent form, understand this clinical study, and are willing to follow and able to complete all trial procedures;\n2. 18-70 years old, male or female;\n3. Subjects with lung nodules confirmed by imaging examination must meet the following conditions:\n\n   Multiple high-risk nodules have been surgically removed and confirmed to be malignant lesions, and the remaining high-risk nodules (refer to the standards in Appendix 12) cannot be surgically removed again, and are not suitable for other effective treatments or have failed other treatments;\n4. If the subject is unable to complete the puncture or the puncture fails, the subject must be diagnosed as a malignant nodule through PET-CT imaging examination.\n\nExclusion Criteria:\n\n1. Subjects who are known to have allergic reactions, hypersensitivity reactions, intolerances or contraindications to any component of KN5001, or subjects with a history of severe allergic reactions;\n2. Subjects with the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome;\n3. Subjects with active or uncontrolled infections requiring parenteral antibiotics; Evidence of a serious active viral or bacterial infection or an uncontrolled systemic fungal infection;\n4. Subjects with heart failure of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standard (see Appendix 1);\n5. Subjects with a history of epilepsy or other central nervous system diseases;\n6. Subjects with a history of malignant tumors, excluding patients with cured skin or cervical carcinoma in situ and patients with inactive tumors;\n7. Subjects with a significant bleeding tendency, such as gastrointestinal bleeding, coagulopathy, hypersplenism, etc.;\n8. Subjects with unstable angina, symptomatic congestive heart failure, or myocardial infarction in the past 6 months;\n9. Females who are pregnant, lactating, or planning a pregnancy within six months;\n10. Subjects who have received other clinical trial treatment within 3 months;\n11. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","70 Years",{"count":54,"type":22},24,"INTERVENTIONAL",[57],"EARLY_PHASE1","A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.",[27,26],"2025-11-24",{"date":62,"type":37},"2025-12-01",{"date":64,"type":37},"2025-09-20",{"date":66,"type":22},"2027-09-20",{"name":68,"class":69},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1]