[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655702":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":22,"armGroups":23,"interventions":18,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":30,"collaborators":32,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":18,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":18,"enrollmentInfo":46,"targetDuration":49,"studyType":50,"phases":18,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":18},{"fullName":5,"class":6},"Shanghai East Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic performance of the AI model for pulmonary nodule malignancy","Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the AI model for classifying benign and malignant nodules, using pathology results or longitudinal stability as the reference standard.","Up to 24 months after enrollment",[14],{"measure":15,"description":16,"timeFrame":17},"Risk stratification accuracy across different nodule sizes","The ability of the AI model to correctly stratify nodules into low, intermediate, and high-risk categories compared to clinical judgement.","Up to 24 months",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","Consecutively enrolled, representative patients (aged ≥18 years, with a maximum nodule diameter of ≥3 mm and ≤30 mm) who underwent chest CT for routine clinical care and were found to have pulmonary nodules, including solid, part-solid, and pure ground-glass nodules.",[24,27],{"label":25,"type":18,"description":26,"interventionNames":18},"Benign Pulmonary Nodule Group","Participants with pulmonary nodules diagnosed as benign, confirmed by either pathological examination or stability on follow-up imaging. No intervention is applied.",{"label":28,"type":18,"description":29,"interventionNames":18},"Malignant Pulmonary Nodule Group","Participants with pulmonary nodules diagnosed as malignant, confirmed by pathological examination. No intervention is applied.",{"type":31,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[33,35],{"name":34,"class":6},"Shanghai Chest Hospital of Shanghai Jiao Tong University",{"name":36,"class":6},"RenJi Hospital","100655702","a-multicenter-cohort-study-of-ai-based-methods-for-pulmonary-nodule-diagnosis-and-follow-up-100655702",false,"NCT07815483","A Multicenter Cohort Study of AI-Based Methods for Pulmonary Nodule Diagnosis and Follow-up","A Prospective, Multicentre Cohort Study of Artificial Intelligence-based Methods for Pulmonary Nodule Segmentation, Benign-Malignant Risk Stratification, and Follow-up","Inclusion Criteria:\n\n(1) Age ≥18 years; (2) At least one non-calcified pulmonary nodule (diameter ≥3 mm and ≤30 mm) detected on chest CT; (3) Agreement to participate in the study and provision of written informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1. Poor CT image quality with severe artifacts that preclude AI-based analysis;\n2. Expected survival \\\u003C12 months or inability to complete follow-up;\n3. History of prior ipsilateral lung malignancy or local treatment. -","ALL","18 Years",{"count":47,"type":48},16880,"ESTIMATED","12 Months","OBSERVATIONAL","This is an observational, multicentre study. The primary objective of this study was to evaluate the diagnostic performance and clinical applicability of artificial intelligence models for pulmonary nodule segmentation, benign-malignant risk stratification, and follow-up management. We will collect CT images and medical data from participants at several hospitals. Participants will not receive any drugs or medical interventions.",[53,54,55],"Pulmonary Nodules","Lung Neoplasms","Artificial Intelligence (AI)",[53,54,57,58,59],"Diagnostic Imaging","Artificial Intelligence","Deep Learning","NOT_YET_RECRUITING","2026-09-08",{"date":63,"type":64},"2026-09-11","ACTUAL",{"date":66,"type":48},"2026-10",{"date":68,"type":48},"2029-10",{"name":5,"class":6}]