[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605935":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":26,"centralContacts":30,"locations":41,"responsibleParty":148,"collaborators":35,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":35,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":44,"whyStopped":35,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"bioAffinity Technologies Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single","EXPERIMENTAL","Diagnostic testing of sputum sample provided by subject",[13],"Other: Standard medical treatment",[15,21],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"OTHER","Standard medical treatment","Standard of care follow up per institution",[9],[18],{"type":16,"name":17,"description":22,"armGroupLabels":23,"otherNames":24},"SOC per institution",[9],[25],"Follow up SOC",[27],{"name":28,"affiliation":5,"role":29},"Maria Zannes","STUDY_CHAIR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Xavier T Reveles, MS, CG(ASCP)","CONTACT","210-698-5334",null,"xr@bioaffinitytech.com",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},"Stacy K Stanek","612-716-7666","stacy.stanek@harvestiro.com",[42,62,78,94,113,128,138],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"VA Palo Alto Health Care System","RECRUITING","Palo Alto","California","94304","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-122.14302,37.44188,{"lat":54,"lon":53},[57],{"name":58,"role":33,"phone":59,"phoneExt":60,"email":61},"Kalyani Raraviker","650-493-5000","66447","Kalyani.Raravikar@va.gov",{"facility":63,"status":44,"city":64,"state":65,"zip":66,"country":48,"countryCode":49,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"VA Western Colorado Health Care System","Grand Junction","Colorado","81501",{"type":51,"coordinates":68},[69,70],-108.55065,39.06387,{"lat":70,"lon":69},[73],{"name":74,"role":33,"phone":75,"phoneExt":76,"email":77},"Lisa Bertrand, RN","970-242-0731","2314","Lisa.Bertrand@va.gov",{"facility":79,"status":44,"city":80,"state":81,"zip":82,"country":48,"countryCode":49,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Bay Pines VA Healthcare System","Bay Pines","Florida","33744",{"type":51,"coordinates":84},[85,86],-82.77816,27.81419,{"lat":86,"lon":85},[89],{"name":90,"role":33,"phone":91,"phoneExt":92,"email":93},"Sarah Crim, CCRC","727-398-6661","17975","Sarah.Crim@va.gov",{"facility":95,"status":44,"city":96,"state":81,"zip":97,"country":48,"countryCode":49,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Miami VA Healthcare System","Miami","33125",{"type":51,"coordinates":99},[100,101],-80.19366,25.77427,{"lat":101,"lon":100},[104,109],{"name":105,"role":33,"phone":106,"phoneExt":107,"email":108},"Gregory E. Holt, MD, PhD","305-575-7000","13208","gregory.holt@va.gov",{"name":110,"role":33,"phone":111,"phoneExt":35,"email":112},"Brian Sturgill, MSN, RN","786-819-0780","brian.sturgill@va.gov",{"facility":114,"status":44,"city":115,"state":116,"zip":117,"country":48,"countryCode":49,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Clinical Research Associates of Central Pennsylvania","DuBois","Pennsylvania","15801",{"type":51,"coordinates":119},[120,121],-78.76003,41.11923,{"lat":121,"lon":120},[124],{"name":125,"role":33,"phone":126,"phoneExt":35,"email":127},"Amber Witherow, RN, BSN","814-661-8837","awitherow@lunginnovations.com",{"facility":129,"status":44,"city":130,"state":131,"zip":132,"country":48,"countryCode":49,"cosmosGeoPoint":133,"geoPoint":137,"contacts":35},"Audie Murphy VA Medical Center","San Antonio","Texas","78234",{"type":51,"coordinates":134},[135,136],-98.49363,29.42412,{"lat":136,"lon":135},{"facility":139,"status":44,"city":130,"state":131,"zip":132,"country":48,"countryCode":49,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Brooke Army Medical Center",{"type":51,"coordinates":141},[135,136],{"lat":136,"lon":135},[144],{"name":145,"role":33,"phone":146,"phoneExt":35,"email":147},"Jessica Pedroza, BSN, RN, OCN","210-916-2995","jpedroza@hjf.org",{"type":149,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100605935","evaluate-the-clinical-performance-of-the-flow-cytometry---flowpath-lung-test-as-a-sensitive-and-specific-non-invasive-diagnostic-of-sputum-samples-to-identifydetect-the-presence-of-lung-cancer-in-high-risk-individuals-who-have-existing-lung-nodules-6-to-30-mm-in-diameter-determined-by-ldct-100605935",false,"NCT07168993","Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify\u002FDetect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to \u003C30 mm in Diameter, Determined by LDCT.","Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline","BA-004","Inclusion Criteria:\n\n1. Is able to give signed informed consent and comply with study requirements.\n2. Is high risk for getting lung cancer:\n\n   1. ≥50 - 80 years of age.\n   2. current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years.\n3. Has a \\>6 to \\\u003C30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 6 weeks of the prestudy baseline CT scan.\n\n3a) Nodule is either new, increasing, or stable for ≤ 6 months. 3b) In cases where a person has multiple nodules as determined by CT scan, the subject's most suspicious nodule is \\>6 to \\\u003C30 mm in diameter.\n\n4\\) Is willing to provide contact information to the study PI or the treating physician(s) who can release required medical information related to SOC follow-up.\n\nExclusion Criteria:\n\n1. Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).\n2. The dominant nodule is ground glass or part solid as determined by CT scan.\n3. Has 5 or more nodules sized \\>4 mm.\n4. The nodule sized \\>6 to \\\u003C30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.\n5. Is immunosuppressed.\n6. Has rheumatoid arthritis.\n7. Had lung cancer diagnosis in the past 5 years or any other cancer (other than non-melanoma skin cancer) in the past 2 years. A subject on long-term medications used for prevention of cancer, such as Tamoxifen for breast cancer, is not excluded.\n8. Has angina with minimal exertion.\n9. Is currently pregnant or planning on becoming pregnant during this study.","ALL","50 Years","80 Years",{"count":162,"type":163},2063,"ESTIMATED","INTERVENTIONAL",[166],"NA","Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \\>6 to \\\u003C30 mm in Diameter, Determined by LDCT.",[169],"Lung Cancer (Diagnosis)",[171,172,173],"Lung Cancer","Diagnostic Test","Sputum Assay","2026-06-09",{"date":176,"type":177},"2026-06-10","ACTUAL",{"date":179,"type":177},"2026-02-25",{"date":181,"type":163},"2029-07-01",{"name":5,"class":6},7]