[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467709":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":53,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":77,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Immunis.AI","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Controls: Patients with negative screening MMG",null,"Patients presenting to Duke Radiology for routine screening mammogram will be screened for eligibility as negative controls. Study enrollment for negative controls presumes that patients do not receive their screening mammography results immediately. Patients will be approached on the day of their first new patient visit to the Duke Cancer Center. If they are willing, they will be consented in clinic, and directed down to the lab for their first blood draw.",[13],"Diagnostic Test: Blood test",{"label":15,"type":10,"description":16,"interventionNames":17},"Cases: Patients with known cancer diagnosis","Patients presenting to the Duke Cancer Center for evaluation by Medical or Surgical Oncology of a newly diagnosed breast cancer will be screened for study eligibility and approached, enrolled, and consented accordingly. Patients will be approached on the day of their first new patient visit to the Duke Cancer Center. If they are willing, they will be consented in clinic, and directed down to the lab for their first blood draw.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Blood test","Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.",[15,9],[25],{"name":26,"affiliation":5,"role":27},"Kirk Wojno, MD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Amanda Nash","CONTACT","855-855-6484","amanda.nash@duke.edu",[35],{"facility":36,"status":10,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Duke University","Durham","North Carolina","27710","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-78.89862,35.99403,{"lat":46,"lon":45},[49,50,51],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":10},{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"name":52,"role":27,"phone":10,"phoneExt":10,"email":10},"Shelley Hwang, MD",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[56],{"name":36,"class":57},"OTHER","100467709","snaps-breast-cancer-patient-study-breast-cancer-patients-100467709",false,"NCT05370300","SNAPS Breast Cancer Patient Study Breast Cancer Patients","Subtraction Normalized Aggregated Phagocytic Signal in Peripheral Blood of Breast Cancer Patients (SNAPS - Clinical Trial) A NextGen RNASeq Feasibility Study of a Blood-based Model for Early Cancer Detection and Surveillance","Inclusion Criteria:\n\n* Patients \\> 18 yrs of age.\n* Patients diagnosed with stage I-IV breast cancer, who have not begun definitive therapy.\n* Patients undergoing screening mammograms for breast cancer.\n\nExclusion Criteria:\n\n* Patients with a history of a different cancer within the previous 3 years (except non melanoma skin cancer).\n* Any prior treatment (surgery, chemo, hormonal, radiation, biologics, etc.) for current cancer.\n* Any biopsy which resulted in the entire tumor tissue being removed.\n* History of previous breast cancer.\n* Patients unable to provide informed consent.\n* Patients with an abnormal screening mammogram.\n* Patients whose hormone receptor and\u002For HER2 status are not available.","FEMALE","18 Years",{"count":68,"type":69},500,"ESTIMATED","OBSERVATIONAL","Differential immunogenomic signatures from peripheral blood CD14 (phagocytic) and CD2 (non-phagocytic) cells have been associated with multiple cancers and disease states. In particular several large clinical studies at Immunis.AI have demonstrated robust immunogenomic signatures in early-stage prostate cancer. Immunis.AI therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls.",[73,74],"Breast Cancer","Breast Cancer Female",[73,76],"Immunogenomics","NOT_YET_RECRUITING","2024-03-05",{"date":80,"type":81},"2024-03-06","ACTUAL",{"date":83,"type":69},"2025-09-01",{"date":85,"type":69},"2027-12-31",{"name":5,"class":6},1]