[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"bioAffinity Technologies Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":21,"type":22},2063,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Lung Cancer (Diagnosis)",[30,31,32],"Lung Cancer","Diagnostic Test","Sputum Assay","RECRUITING","2026-06-09",{"date":36,"type":37},"2026-06-10","ACTUAL",{"date":39,"type":37},"2026-02-25",{"date":41,"type":22},"2029-07-01",{"name":43,"class":44},"bioAffinity Technologies Inc.","INDUSTRY",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100320867","collection-of-sputum-and-labeling-for-lung-cancer-100320867","NCT03457415","Collection of Sputum and Labeling for Lung Cancer","Collection of Sputum and Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer","Inclusion Criteria:\n\nEach subject must meet the following criteria to be enrolled in this study:\n\n* Male or female\n* 21 years of age or older\n* Willing to provide primary care physician contact information to the investigator and agree to have medical information released if indicated\n* Meet requirements of one of three cohorts in the study:\n\nHealthy Cohort: Current non-smoker who has smoked less than 5 pack-years in his or her lifetime, and if smoked, quit more than 15 years ago, and has no known lung disease.\n\nHigh Risk Cohort: Individual aged ≥55-74 who is a current smoker with a smoking history of at least 30 pack-years, or current non-smoker who has a smoking history of at least 30 pack-years, and quit smoking within the past 15 years.\n\nCancer Cohort: Individual who has been diagnosed by a physician as highly suspect for having lung cancer but has not yet undergone a biopsy nor received therapy, and after providing a sputum sample is confirmed to have lung cancer by biopsy.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n* Severe obstructive lung disease and unable to cough with sufficient exertion to produce a sputum sample. Participants with lung disease that are able to cough with sufficient exertion to produce a sputum sample are not excluded from the study\n* Angina with minimal exertion\n* Pregnancy",true,"21 Years",{"count":56,"type":22},500,"OBSERVATIONAL","The primary objective of this study is to compare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Participants using the Assay as developed in accordance with findings of bioAffinity protocol BA-001 to confirm assay results. Adjustments will be made as necessary to finalize Assay design for clinical trials and commercialization.\n\nThe secondary objective of this study is to determine optimum methods for collection of sputum samples. Three sputum collection methods used by high risk Participants will be compared. Individuals at high risk for lung cancer will be assigned to one of three sputum collection cohorts including (1) acapella® airway assist device under medical supervision to obtain a single sputum sample; (2) acapella® airway assist device to obtain a sputum sample over a three-day period, and (3) individuals who under medical supervision will collect a single sputum sample assisted by nebulization of between 0.9% to 10% hypertonic saline. Samples will be compared to determine the optimal collection method for sample analysis by CyPath® Lung.",[30],[61,62,63,64,65],"LDCT","Sputum","High-risk Smoker","Porphyrin","Early detection","2025-03-26",{"date":68,"type":37},"2025-04-01",{"date":70,"type":37},"2018-03-01",{"date":72,"type":22},"2025-12",{"name":43,"class":44},3,""]