[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635430":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":28,"locations":38,"responsibleParty":62,"collaborators":18,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Vejle Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Risk stratification","EXPERIMENTAL","Risk stratification for lung cancer using standard blood tests, machine learning and a DNA methylation analysis.",[13],"Other: Risk stratification",[15],{"type":6,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"Patients with COPD will have their risk of lung cancer evaluated using a machine learning model incorporating clinical data and standard blood tests as well as a DNA methylation biomarker. If the risk of lung cancer is above the cut-off, the patient will be referred for a low-dose CT scan of the chest. Currently smoking patients will be referred for a smoking cessation program.",[9],null,[20,24],{"name":21,"affiliation":22,"role":23},"Ole Hilberg, MD, DMSc","Department of Medicine, Lillebaelt Hospital Vejle, University Hospital of Southern Denmark","STUDY_CHAIR",{"name":25,"affiliation":26,"role":27},"Sara Witting Christensen Wen, MD, PhD","Department of Biochemistry and Immunology, Lillebaelt Hospital Vejle, University Hospital of Southern Denmark","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Sara Witting Christensen WC Wen, MD, PhD","CONTACT","+45 79406511","sara.witting.christensen.wen@rsyd.dk",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Lene Horsted, Study nurse","+45 79409946","breathe@rsyd.dk",[39,55],{"facility":40,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Lillebaelt Hospital Vejle, University Hospital of Southern Denmark","RECRUITING","Vejle","7100","Denmark","DK",{"type":47,"coordinates":48},"Point",[49,50],9.5357,55.70927,{"lat":50,"lon":49},[53,54],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},{"facility":56,"status":41,"city":42,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"General practices, Vejle area",{"type":47,"coordinates":58},[49,50],{"lat":50,"lon":49},[61],{"name":25,"role":31,"phone":36,"phoneExt":18,"email":37},{"type":63,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100635430","blood-based-risk-evaluation-with-ai-for-targeted-primary-health-care-in-early-lung-cancer-detection-100635430",false,"NCT07552584","Blood Based Risk Evaluation With AI for Targeted Primary Health Care in Early Lung Cancer Detection","BREATHE","Inclusion Criteria:\n\n* Diagnosed with COPD.\n* =\\> 50 years.\n* Former or current smoker.\n* Speaks and understands Danish.\n* Able to give informed consent to participation.\n\nExclusion Criteria:\n\n* Had a CT scan of the thorax within 6 months.\n* Received active treatment for cancer within one year (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).\n* Diagnosed with cancer within one year (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).\n* Presents with symptoms giving suspicion of cancer (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).\n* In a condition not allowing diagnostic workup for or treatment of lung cancer.\n* Does not have Eboks (electronic communication with Danish authorities).","ALL","50 Years",{"count":74,"type":75},1000,"ESTIMATED","INTERVENTIONAL",[78],"NA","The study is a prospective, non-randomized feasibility study evaluating blood sample and machine learning-based risk stratification for lung cancer in patients with COPD (chronic obstructive pulmonary disease).\n\nPatients with COPD will be recruited in general practice, where they will have a blood sample drawn. All data will be analyzed by the machine learning model, and patients with increased risk of lung cancer will be referred for a low-dose CT scan of the chest.\n\nThe primary objective of the study is to evaluate the feasibility of AI and DNA methylation-based risk stratification for lung cancer in patients with COPD in a primary care setting.\n\nThe secondary objectives are to evaluate the safety of the risk stratification approach, the potential effects on quality of life and wellbeing, to gain insight into the patient and physician perspectives, and to estimate the health economic consequences.",[81],"Lung Cancer (Diagnosis)",[83,84,85,9,86],"Lung cancer","Biomarkers","Machine learning","COPD","2026-06-02",{"date":89,"type":90},"2026-06-03","ACTUAL",{"date":92,"type":90},"2026-05-26",{"date":94,"type":75},"2034-04",{"name":5,"class":6},2]