[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100345212":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":42,"centralContacts":46,"locations":52,"responsibleParty":87,"collaborators":89,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":10,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":10,"enrollmentInfo":104,"targetDuration":107,"studyType":108,"phases":10,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1A: Benign nodule on screening CT",null,"High-risk patients eligible for lung cancer screening but with negative radiographic findings on CT screening (Lung RADS ≤2).\n\n1. ≥30 pack-year history of cigarette smoking\n2. ≥55 years of age\n3. Current smoker or quit within the past 15 years",[13],"Diagnostic Test: Guardant Health ct-DNA LUNAR assay",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 1B: Incidental benign nodule","Patients with lung nodules ≥ 6 mm on routine (non-lung cancer screening) CT evaluation deemed suspicious for malignancy by initial physician judgment but not malignant by ≥2 years of radiographic stability and consensus clinical opinion.\n\n1- Age ≥40 years.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort IC: Presumed lung cancer","Patients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy.\n\n1- Age ≥40 years.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 2A: Suspicious nodule","High-risk patients with newly diagnosed suspicious nodule of Lung RADS ≥3 on CT screening.\n\n1. ≥30 pack-year history of cigarette smoking\n2. ≥55 years of age\n3. Current smoker or quit within the past 15 years",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 2B: Suspicious incidental nodule","Patients with newly diagnosed incidentally-found lung nodules ≥ 6 mm on routine CT evaluation deemed suspicious for malignancy by physician judgment.\n\n1- Age ≥40 years.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Cohort 2C: Post-treatment lung cancer","Patients with previously treated lung cancer (histologically proven or by consensus opinion); status-post completion of definitive therapy (resection +\u002F- chemotherapy or SBRT with curative intent) within the previous year with no current evidence of disease.\n\n1- Age ≥40 years.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DIAGNOSTIC_TEST","Guardant Health ct-DNA LUNAR assay","Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease.",[9,15,23,27,31,19],[41],"Liquid biopsy Using NGS to Assay high-Risk patients",[43],{"name":44,"affiliation":5,"role":45},"Mehrdad Arjomandi, M.D.","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},"Mehrdad Arjomandi, MD","CONTACT","877-827-3222","cancertrials@ucsf.edu",[53,70,79],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Zuckerberg San Francisco General Hospital and Trauma Center","RECRUITING","San Francisco","California","94110","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-122.41942,37.77493,{"lat":65,"lon":64},[68,69],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},{"name":44,"role":45,"phone":10,"phoneExt":10,"email":10},{"facility":71,"status":55,"city":56,"state":57,"zip":72,"country":59,"countryCode":60,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"San Francisco VA Medical Center","94121",{"type":62,"coordinates":74},[64,65],{"lat":65,"lon":64},[77,78],{"name":44,"role":49,"phone":50,"phoneExt":10,"email":51},{"name":44,"role":45,"phone":10,"phoneExt":10,"email":10},{"facility":5,"status":55,"city":56,"state":57,"zip":80,"country":59,"countryCode":60,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"94122",{"type":62,"coordinates":82},[64,65],{"lat":65,"lon":64},[85,86],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},{"name":44,"role":45,"phone":10,"phoneExt":10,"email":10},{"type":88,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[90,92],{"name":91,"class":6},"Northern California Institute of Research and Education",{"name":93,"class":94},"Guardant Health, Inc.","INDUSTRY","100345212","biomarkers-for-risk-stratification-in-lung-cancer-100345212",false,"NCT03774758","Biomarkers for Risk Stratification in Lung Cancer","Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening","Inclusion Criteria:\n\n* Age ≥ 40 years\n* Ability to understand and provide written informed consent\n* Willingness to comply with study protocols and provide blood samples.\n* Willingness to complete 3-year clinical follow up\n\nExclusion Criteria:\n\n* Active non-cutaneous malignancy within the past 5 years as per medical record or patient report.\n* Exclusion criteria for possible follow-up visit blood draw:\n* Anemia - measured by hematocrit level of less than 30%, measured after the first blood draw.\n* Malnourishment - determined by BMI less than 19. If subject has BMI greater or equal to 19, but has a history of malnourishment, study staff will measure albumin level of subject's blood after initial blood draw. Albumin level must be greater than 2.5 mg per deciliter, or subject will be excluded.\n* Severe Chronic Obstructive Pulmonary Disease (COPD) - defined by Gold Stage IV.\n* Unstable heart conditions - defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active congestive heart failure, ischemic cardiomyopathy, or history of complications because of previous blood donation.\n* Liver cirrhosis.","ALL","40 Years",{"count":105,"type":106},590,"ESTIMATED","3 Years","OBSERVATIONAL","This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, University of California, San Francisco (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.",[111,112],"Nodule Solitary Pulmonary","Non-small Cell Lung Cancer",[114,115,116,117,118],"Lung cancer screening","Biomarkers of lung cancer","Circulating tumor DNA","Low dose computed tomography of lung","Pulmonary nodule","2026-06-01",{"date":121,"type":122},"2026-06-04","ACTUAL",{"date":124,"type":122},"2017-12-17",{"date":126,"type":106},"2030-12-31",{"name":5,"class":6},3]