[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659617":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":11,"studyPopulation":11,"armGroups":24,"interventions":32,"overallOfficials":42,"centralContacts":49,"locations":55,"responsibleParty":69,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":11,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":96,"whyStopped":11,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Pro-N-Cadherin biomarker level measured in ng\u002Fml",null,"Baseline, prior to starting radiation therapy (approximately 2 weeks); 6, 12, 18, and 24 months post completion of radiation therapy",{"measure":14,"description":11,"timeFrame":12},"Change in Pro-N-Cadherin biomarker level from baseline",{"measure":16,"description":11,"timeFrame":17},"Number of participants with cardiac events","6, 12, 18, and 24 months post completion of radiation therapy",{"allocation":19,"interventionModel":20,"interventionModelDescription":11,"primaryPurpose":21,"observationalModel":11,"timePerspective":11,"maskingInfo":22},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":23,"maskingDescription":11,"whoMasked":11},"NONE",[25],{"label":26,"type":27,"description":28,"interventionNames":29},"Adults with non-small cell lung cancer","EXPERIMENTAL","Adults with non-small cell lung cancer receiving hypofractionated radiation therapy will undergo biomarker testing and echocardiographic assessments.",[30,31],"Diagnostic Test: Serum Pro-N-Cadherin Biomarker Assessment","Diagnostic Test: Echocardiogram",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"DIAGNOSTIC_TEST","Serum Pro-N-Cadherin Biomarker Assessment","Serial blood collection for measurement of Pro-N-Cadherin and NT-proBNP (pro B-type natriuretic peptide) at baseline and follow-up timepoints, with correlation to cardiac radiation dose and outcomes.",[26],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"Echocardiogram","Participants will undergo two echocardiograms to measure heart function.",[26],[43,47],{"name":44,"affiliation":45,"role":46},"Christopher Kelsey, MD","Duke Health","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":45,"role":46},"Chang-Lung Lee, PhD",[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Clinical Trials Office","CONTACT","(919) 668-3726","RadOnc-Clinical_Trials@dm.duke.edu",[56],{"facility":57,"status":11,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":11},"Duke University Medical Center","Durham","North Carolina","27710","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-78.89862,35.99403,{"lat":67,"lon":66},{"type":70,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[72],{"name":73,"class":74},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100659617","biomarker-testing-to-predict-radiation-related-heart-disease-in-lung-cancer-patients-100659617",false,"NCT07869329","Biomarker Testing to Predict Radiation-Related Heart Disease in Lung Cancer Patients","Predicting Radiation-induced Cardiac Disease With the Biomarker Serum Pro-N-Cadherin","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Histologic documentation or clinical suspicion of non-small cell lung cancer based on pathology or imaging.\n* Location of disease must be either a central right-sided tumor (defined as tumors with a planning target volume within 2 cm of the primary airways) arising below the level of the heart or any left-sided tumor arising below the level of the heart.\n* Planned to receive hypofractionated radiation therapy (4-18 Gy fractions to a total dose of 45-70 Gy)\n* Planning the target volume that is at or below the most superior aspect of the heart.\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Planning to receive concurrent or sequential chemotherapy or immunotherapy\n* Prior radiation therapy to the chest that included more than a minimal dose to the heart (\\> 1 Gy mean dose).","ALL","18 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[19],"The study will measure serum Pro-N-Cadherin and NT-proBNP (pro B-type natriuretic peptide) levels in adults with non-small cell lung cancer receiving hypofractionated radiation therapy and evaluate whether these biomarkers correlate with radiation dose to the heart, cardiac dysfunction, and adverse cardiac events. Participants will undergo blood collection and echocardiography over a two-year follow-up period.",[91,92],"Non-Small Cell Lung Cancer","Radiation-Induced Cardiac Disease",[94,95,91],"Biomarkers","Radiation-Induced Heart Disease","NOT_YET_RECRUITING","2026-10-06",{"date":99,"type":100},"2026-10-09","ACTUAL",{"date":102,"type":86},"2026-11",{"date":104,"type":86},"2030-11",{"name":5,"class":6},1]