[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"First Ascent Biomedical Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100605812","xdrive-for-florida-based-cancer-patients-100605812",false,"NCT07167381","xDRIVE for Florida-based Cancer Patients","xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed\u002F Refractory Cancers","Inclusion Criteria:\n\n* Patients with recurrent\u002Frefractory cancer patients up to age 18 (willing to sign assent if ages 7 - 17 years)\n* -OR- Patients with recurrent\u002Frefractory cancer ≥18 years of age.\n* Patients who have received at least one prior line of standard of care therapy.\n* Patients able to provide treatment and outcome information from previous line(s) of therapy.\n* Patients with sufficient health status to undergo cancer therapy, e.g., Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2 for adult patients.\n* Patients who are scheduled for or have recently undergone a tumor biopsy, excision, or resection.\n* Patients willing to have a blood draw or buccal swab performed for matched normal material for comparison during tumor DNA profiling.\n\nExclusion Criteria:\n\n* Patients who do not have malignant tissue available and accessible, patients where the amount of excised malignant tissue is insufficient material for ex vivo drug testing and\u002For genetic profiling, defined as \\\u003C0.3g for resections or core\u002Ffine-needle biopsies not containing malignant tissue by pathology review, or insufficient malignant tissue in peripheral blood or bone marrow aspirate samples.\n* Patients with insufficient health indicators to undergo therapeutic intervention.","ALL",{"count":18,"type":19},210,"ESTIMATED","INTERVENTIONAL",[22],"NA","Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. The investigator will run a prospective single-arm feasibility study providing the xDRIVE FPM AI platform to n = 210+ cancer patients throughout the state of Florida, especially those from underserved populations (pediatric patients and patients in Black, Brown, Hispanic, and rural communities).",[25,26,27,28,29,30,31,32],"Cancer","Neoplams","Refractory","Recurrence","Leukaemia","Lymphoma","Solid Tumor Malignancies","Solid Cancers",[34,35],"Functional Precision Medicine","Artificial Intelligence","RECRUITING","2026-05-17",{"date":39,"type":40},"2026-05-19","ACTUAL",{"date":42,"type":40},"2025-11-01",{"date":44,"type":19},"2027-04-01",{"name":46,"class":47},"First Ascent Biomedical Inc.","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100587511","xdrive-in-metastatic-colorectal-cancer-100587511","NCT06929338","xDRIVE in Metastatic Colorectal Cancer","A Feasibility Study to Evaluate a Precision Oncology Platform (xDRIVE) in Participants With Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Participants (men and women) enrolled in internal review board (IRB) 622-00 and meet the following criteria.\n* Participants ≥18 years of age with a diagnosis of mCRC who are willing to consent to the study\n* Participants with Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2.\n* Participants with measurable disease\n* Participants who need to start SOC cancer-directed systemic therapy\n* Participants able to provide treatment and outcome information from previous lines of therapy.\n* Participants who will need a tumor biopsy, excision, or resection as part of their routine clinical care.\n* Participants willing to have a blood draw performed for matched normal material.\n* Participants who plan to have their first radiographic assessment of their cancer at Mayo Clinic.\n\nExclusion Criteria:\n\n* Participants who do not have malignant tissue available or safely accessible or do not have sufficient amount of tissue from anticipated biopsy, excision or resection for testing.\n* Participants who do not have measurable disease.\n* Participants with insufficient health indicators to undergo therapeutic intervention for mCRC based on treating oncologist's clinical assessment.\n* Participants with other concurrent cancers besides mCRC which also require ongoing cancer-directed therapy.\n* Participants who cannot provide an informed consent.","18 Years",{"count":57,"type":19},30,"OBSERVATIONAL","The study aims to evaluate the clinical utility of the xDRIVE functional precision medicine + artificial intelligence (AI) platform in predicting treatment response for metastatic colorectal cancer (mCRC). The primary objective is to assess xDRIVE's accuracy in forecasting clinical benefit from standard-of-care (SOC) therapies, with a target of ≥80% accuracy in 25 participants. Achieving this threshold would provide sufficient statistical power to reject the null hypothesis of ≤50% accuracy.\n\nThe secondary goal is to determine the feasibility of utilizing xDRIVE for timely treatment recommendations. Success will be defined by the ability to provide recommendations within four weeks for at least 64% of patients, ensuring clinical applicability.\n\nAdditionally, the study includes an exploratory objective to examine oncologists' perspectives on integrating xDRIVE into clinical decision-making. This will be achieved through a post-hoc survey assessing physician experiences with the precision oncology platform.",[61,62,63,64,65],"Metastatic Colon Adenocarcinoma","Metastatic Colon Cancer","Metastatic Rectal Adenocarcinoma","Metastatic Rectal Carcinoma","Metastatic Rectum Cancer",[67,68,69,70],"functional precision medicine","artificial intelligence","molecular tumor profiling","metastatic colorectal cancer","NOT_YET_RECRUITING","2025-09-10",{"date":74,"type":40},"2025-09-16",{"date":76,"type":19},"2025-09-15",{"date":78,"type":19},"2027-06-30",{"name":46,"class":47},""]