[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469309":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":54,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":11,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Kentucky","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Genocare Guided","EXPERIMENTAL",null,[13],"Drug: Irinotecan",{"label":15,"type":16,"description":11,"interventionNames":11},"Usual Care","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Irinotecan","Usual dosing per package insert.",[9],[24,25],"Nano-liposomal Irinotecan","Onyvide",[27],{"name":28,"affiliation":5,"role":29},"Reema A Patel, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":11,"email":34},"CONTACT","8592186650","reema.patel@uky.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Lexington","Kentucky","40506","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-84.47772,37.98869,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":11,"email":53},"Yvonne Taul","859-323-2354","Yvonne.Taul@uky.edu",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Reema A. Patel","Assistant Professor","100469309","genocare-a-prospective-randomized-clinical-trial-of-genotype-guided-dosing-versus-usual-care-100469309",false,"NCT05391126","GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care","Inclusion Criteria:\n\n* Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.\n* Prior treatment is allowed, specifically surgery and\u002For radiation and non-irinotecan containing regimens are allowed.\n* Age ≥ 18 years.\n* ECOG performance status ≤ 1.\n* Patients must have adequate organ and marrow function as defined below:\n* Measurable or non-measurable disease.\n\nExclusion Criteria:\n\n* Patients who received prior treatment with irinotecan are excluded.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with targeted therapy, in the opinion of the treating physician.\n* Pregnant women are excluded from this study.\n* Patients who are not planned for treatment of their cancer.","ALL","18 Years",{"count":67,"type":68},178,"ESTIMATED","INTERVENTIONAL",[71],"NA","This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (\\*1\u002F\\*28) (heterozygotes) and usual UGT metabolizers (\\*1\u002F\\*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (\\*1\u002F\\*28, \\*1\u002F\\*1) will be randomized to genotype-guided dosing versus usual care.",[74,75],"Colorectal Cancer","Pancreatic Cancer","2025-12-08",{"date":78,"type":79},"2025-12-16","ACTUAL",{"date":81,"type":79},"2022-09-28",{"date":83,"type":68},"2027-05",{"name":56,"class":6},1]