[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584961":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":20,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":93,"overallStatus":46,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"The potential candidates for genome-informed targeted therapy","Potential candidates have a stage IV solid tumor malignancy (breast, lung, colorectal, and bladder cancer) for whom NGS testing is planned to be obtained before first or second-line therapy.",[12,13,14],"Other: Expert Review","Other: Blood or tissue samples collection.","Other: The Precision Oncology Navigation",[16,21,25],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"Expert Review","Expert reflexive review of next-generation sequencing (NGS) results will be visible in electronic health records (EPIC) for provider review at the University of North Carolina Health System. Expert review will include recommendations for Genome-informed therapy (GIT), identification of available clinical trials, recommendations for additional testing, and\u002For referrals for genetic counseling.",[9],null,{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Blood or tissue samples collection.","Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":20},"The Precision Oncology Navigation","The precision oncology navigator will coordinate the collection of blood and \u002For tissue for next-generation sequencing (NGS), as well as order the NGS if not already ordered. Precision oncology navigator will also assist in NGS financial aid applications, if applicable.",[9],[30],{"name":31,"affiliation":5,"role":32},"Carrie Lee","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":20,"email":38},"Stephanie Drotts","CONTACT","919-445-4872","stephanie_drotts@med.unc.edu",{"name":40,"role":36,"phone":41,"phoneExt":20,"email":42},"Douglas Kirk","919-445-6240","douglas_kirk@med.unc.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Lineberger Comprehensive Cancer Center, University of North Carolina","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-79.05584,35.9132,{"lat":56,"lon":55},[59,63],{"name":60,"role":36,"phone":61,"phoneExt":20,"email":62},"Carrie Lee, MD","919-966-0405","carrie_lee@med.unc.edu",{"name":60,"role":32,"phone":20,"phoneExt":20,"email":20},{"type":65,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[67],{"name":68,"class":69},"Eli Lilly and Company","INDUSTRY","100584961","progress-precision-oncology-using-genomic-reflexive-evaluations-for-study-selection-and-survival-100584961",false,"NCT06896162","PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival","PROGRESS","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* ECOG or Karnofsky Performance Status of 0-2.\n* Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer\n* The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting\n* A genomic tumor test has not been ordered or has been ordered but not resulted.\n\nExclusion Criteria:\n\n• Subjects with an active concurrent malignancy.","ALL","18 Years",{"count":80,"type":81},500,"ESTIMATED","INTERVENTIONAL",[84],"NA","This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers).\n\nThe purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1\u002F2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.",[87,88,89,90,91,92],"Solid Tumor Malignancies","Metastatic Cancer","Breast Cancer","Colorectal Cancer","Lung Cancer","Bladder Cancer",[94,95,96,97,98,99],"next-generation sequencing (NGS)","expert review of NGS","precision oncology","precision oncology navigator","genome informed therapy (GIT)","biomarker-directed clinical trials","2026-07-10",{"date":102,"type":103},"2026-07-14","ACTUAL",{"date":105,"type":103},"2025-06-27",{"date":107,"type":81},"2028-06",{"name":5,"class":6},1]