[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511126":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":10,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Guardant Health, Inc.","INDUSTRY",[8,14,17,20,23,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Unresectable Stage III\u002FIV NSCLC",null,"Blood samples collected will be banked",[13],"Diagnostic Test: Guardant360",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2: Stage IV Colorectal",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Cohort 3: Unresectable Stage III\u002FIV Breast - HR+ HER2-",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Cohort 4: Unresectable Stage III\u002FIV Breast - HR- HER2+",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Cohort 5: Unresectable Stage III\u002FIV Breast - HR+ HER2+",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"Cohort 6: Unresectable Stage III\u002FIV Breast - Triple Negative",[13],[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"DIAGNOSTIC_TEST","Guardant360","Guardant360 is a qualitative next generation sequencing (NGS)-based in vitro diagnostic device for detection of single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions in genes frequently mutated in cancer, using circulating cell-free DNA (cfDNA) obtained from the plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes.",[9,15,18,21,24,27],[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Clinical Trial Operations","CONTACT","8556988887","sibyl@guardanthealth.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Orchard Healthcare Research Inc.","RECRUITING","Skokie","Illinois","60077-1384","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-87.73339,42.03336,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":10,"phoneExt":10,"email":10},"Ira Oliff",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100511126","sibyl-observation-of-therapy-response-with-liquid-biopsy-evaluation-100511126",false,"NCT05935384","SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation","Inclusion Criteria\n\nEach participant must satisfy all the following criteria to be enrolled in the study:\n\n1. Age ≥18 years old\n2. Are treated with systemic therapy and\u002For oral SOC regimen at the site of enrollment during entirety of study\n3. Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy\n4. Able to understand, and capable of providing written consent to participate in the study\n5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent\n6. Are willing to provide blood samples at enrollment and at subsequent clinical visits\n7. Have a histologically confirmed Index cancer that qualifies for inclusion, defined as:\n\n   * Cohort 1: Unresectable Stage III\u002FIV NSCLC (\\~125)\n   * Cohort 2: Stage IV Colorectal (\\~125)\n   * Cohort 3: Unresectable Stage III\u002FIV Breast - HR+ HER2- (\\~55)\n   * Cohort 4: Unresectable Stage III\u002FIV Breast - HR- HER2+ (\\~55)\n   * Cohort 5: Unresectable Stage III\u002FIV Breast - HR+ HER2+ (\\~55)\n   * Cohort 6: Unresectable Stage III\u002FIV Breast - Triple Negative (\\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.\n\nExclusion Criteria\n\nAny potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:\n\n1. History of prior solid malignancy or hematological malignancy within five years of enrollment\n2. Life expectancy ≤12 weeks\n3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen\n4. Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting\u002Fpredicting clinical response\u002Fprogression","ALL","18 Years",{"count":70,"type":71},470,"ESTIMATED","OBSERVATIONAL","The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.",[75,76,77],"Non-small Cell Lung Cancer","Colorectal Cancer","Breast Cancer","2025-08-18",{"date":80,"type":81},"2025-08-22","ACTUAL",{"date":83,"type":81},"2023-10-25",{"date":85,"type":71},"2030-12-30",{"name":5,"class":6},1]