[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastro-intestinal-intraepithelial-neoplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastro-intestinal-intraepithelial-neoplasia":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100605103",false,"NCT07158164","DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment","Inclusion Criteria:\n\n* Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine.\n* DPYD testing performed by a CLIA-certified laboratory (i.e., Guardant 360 or Caris blood testing for genomic profiling, DPYD testing by the Mayo Clinic or other certified laboratory) with results available before starting chemotherapy.\n* DPYD testing results falling into one of the following cohorts for first-line therapy with a fluoropyridine:\n* Study Cohort: Patients with one DPYD variant in one gene (heterozygotes).\n* Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose.\n\n  --FOLFOX regimen (N=50)\n* ECOG Performance Status 0-2.\n* Measurable disease or non-measurable disease allowed, including adjuvant 5-FU-based regimens.\n\nExclusion Criteria:\n\n* Patients for whom 5-FU or Capecitabine therapy is contraindicated or not deemed appropriate in the judgment of the treating physician.\n* Patients with two DPYD variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities) should not receive 5-FU or Capecitabine and are therefore excluded from the study.\n* Pregnant Women and Children","ALL","18 Years",{"count":17,"type":18},100,"ESTIMATED","INTERVENTIONAL",[21],"PHASE4","To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm.",[24,25,26,27],"Colorectal Neoplasms","Breast Neoplasms","Head and Neck Neoplasms","Gastro-Intestinal Intraepithelial Neoplasia",[29,30,31,32,33],"colorectal cancer","breast cancer","head and neck cancer","Gastro-Intestinal cancer","chemotherapy toxicity","RECRUITING","2025-11-11",{"date":37,"type":38},"2025-11-13","ACTUAL",{"date":40,"type":38},"2025-08-27",{"date":42,"type":18},"2029-07-07",{"name":44,"class":45},"Rutgers, The State University of New Jersey","OTHER",12,""]