[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100304491":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":10,"locations":29,"responsibleParty":88,"collaborators":10,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":10,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":10,"enrollmentInfo":99,"targetDuration":10,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":109,"whyStopped":10,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"POC Medical Systems, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Breast Cancer Positive",null,"A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were positive.\n\nMammoAlert Screening Test will be performed on plasma obtained from the blood sample.",[13],"Other: MammoAlert Screening Test",{"label":15,"type":10,"description":16,"interventionNames":17},"Breast Cancer Negative","A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were negative.\n\nMammoAlert Screening Test will be performed on plasma obtained from the blood sample.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"OTHER","MammoAlert Screening Test","Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.",[15,9],[25],{"name":26,"affiliation":27,"role":28},"Raghu Ram Pillarisetti, MD","KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals","PRINCIPAL_INVESTIGATOR",[30,36,39,50,60,69,79],{"facility":27,"status":10,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Hyderabad","Andhra Pradesh","500003","India","IN",{"facility":37,"status":10,"city":31,"state":32,"zip":38,"country":34,"countryCode":35,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Indo American Cancer Hospital and Research Institute","500034",{"facility":40,"status":10,"city":41,"state":42,"zip":43,"country":34,"countryCode":35,"cosmosGeoPoint":44,"geoPoint":49,"contacts":10},"HCG MULTI Specialty Hospital HCG Cancer Center","Ahmedabad","Gujarat","380006",{"type":45,"coordinates":46},"Point",[47,48],72.58727,23.02579,{"lat":48,"lon":47},{"facility":51,"status":10,"city":52,"state":53,"zip":54,"country":34,"countryCode":35,"cosmosGeoPoint":55,"geoPoint":59,"contacts":10},"Manipal Hospital","Bangalore","Karnataka","560017",{"type":45,"coordinates":56},[57,58],77.59369,12.97194,{"lat":58,"lon":57},{"facility":61,"status":10,"city":62,"state":63,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"Amrita Institute of Medical Sciences and Research Centre","Kochi","Kerala",{"type":45,"coordinates":65},[66,67],76.26022,9.93988,{"lat":67,"lon":66},{"facility":70,"status":10,"city":71,"state":72,"zip":73,"country":34,"countryCode":35,"cosmosGeoPoint":74,"geoPoint":78,"contacts":10},"Tata Medical Center","Kolkata","West Bengal","700160",{"type":45,"coordinates":75},[76,77],88.36304,22.56263,{"lat":77,"lon":76},{"facility":80,"status":10,"city":81,"state":10,"zip":82,"country":34,"countryCode":35,"cosmosGeoPoint":83,"geoPoint":87,"contacts":10},"Maulana Azad Medical College University of Delhi & Associated Lok Nayak Hospital","New Delhi","110002",{"type":45,"coordinates":84},[85,86],77.2148,28.62137,{"lat":86,"lon":85},{"type":89,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100304491","performance-of-mammoalert-point-of-care-system-for-the-screening-of-breast-cancer-in-women-18-years-of-age-or-older-100304491",false,"NCT03243877","Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older","Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.","Inclusion Criteria:\n\n1. Ability to give informed consent. Written informed consent by the patient\u002Fpatient's legally acceptable representative (LAR) for donating blood sample\n2. Documented absence of cancer (other than Breast Cancer)\n3. Documented (Mammography and\u002For Biopsy) diagnosis of Breast Cancer (IDC\u002FILC\u002FDCIS ), any stage\n4. Blood sample taken before any treatment for Breast Cancer was administered to the subject.\n\nExclusion Criteria:\n\n1. Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.\n2. Therapies for breast cancer that have been administered within 1 year of obtaining the sample\n3. Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.","FEMALE","18 Years",{"count":100,"type":101},2458,"ACTUAL","OBSERVATIONAL","POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. The present study aims to determine the Sensitivity and Specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.",[105],"Breast Cancer",[107,108],"Screening","Mammography","UNKNOWN","2018-04-10",{"date":112,"type":101},"2018-04-11",{"date":114,"type":101},"2017-06-17",{"date":116,"type":117},"2018-08-31","ESTIMATED",{"name":5,"class":6},7]