Clinical trial · Interventional
xDRIVE for Florida-based Cancer Patients
xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed/ Refractory Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Leukaemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neoplams | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
| Refractory | — | UNRESOLVED | — |
| Solid Cancers | Malignant Solid Neoplasm | ALIAS | 0.90 |
| Solid Tumor Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| xDRIVE Tumor Profiling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- xDRIVE Profiling
- description
- Patients will receive tumor profiling via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis
- interventionNames
- Diagnostic Test: xDRIVE Tumor Profiling
Primary outcomes (1)
- measure
- Return of treatment recommendations from xDRIVE functional precision medicine platform within a clinically-actionable timeframe
- timeFrame
- Return of xDRIVE data will be completed in under 2 weeks
- description
- Tumor tissues provided by patients will undergo drug sensitivity testing and molecular tumor profiling in order to identify individualized treatment options. Treatment recommendations from both tumor profiling methods will be returned to the patient and physician to support clinical decision-making. Return of data in a timeframe fast enough to support decision-making is critical for showing clinical feasibility of this approach around the state of Florida. Feasibility will be demonstrated if xDRIVE treatment recommendations are returned within 2 weeks for at least 151 of 210 patients (72%), which is sufficient to reject the null hypothesis (≤60% of patients receiving treatment recommendations) with \>95% power (α = 0.025).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with recurrent/refractory cancer patients up to age 18 (willing to sign assent if ages 7 - 17 years) * -OR- Patients with recurrent/refractory cancer ≥18 years of age. * Patients who have received at least one prior line of standard of care therapy. * Patients able to provide treatment and outcome information from previous line(s) of therapy. * 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. * Patients who are scheduled for or have recently undergone a tumor biopsy, excision, or resection. * Patients willing to have a blood draw or buccal swab performed for matched normal material for comparison during tumor DNA profiling. Exclusion Criteria: * 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/or genetic profiling, defined as \<0.3g for resections or core/fine-needle biopsies not containing malignant tissue by pathology review, or insufficient malignant tissue in peripheral blood or bone marrow aspirate samples. * Patients with insufficient health indicators to undergo therapeutic intervention.
References
Publications (2)
- BACKGROUNDAcanda de la Rocha AM, Berlow NE, Azzam DJ. Functional precision medicine: the future of cancer care. Trends Mol Med. 2025 May;31(5):404-408. doi: 10.1016/j.molmed.2024.10.015. Epub 2024 Nov 19. PMID 39567286
- BACKGROUNDAcanda De La Rocha AM, Berlow NE, Fader M, Coats ER, Saghira C, Espinal PS, Galano J, Khatib Z, Abdella H, Maher OM, Vorontsova Y, Andrade-Feraud CM, Daccache A, Jacome A, Reis V, Holcomb B, Ghurani Y, Rimblas L, Guilarte TR, Hu N, Salyakina D, Azzam DJ. Feasibility of functional precision medicine for guiding treatment of relapsed or refractory pediatric cancers. Nat Med. 2024 Apr;30(4):990-1000. doi: 10.1038/s41591-024-02848-4. Epub 2024 Apr 11. PMID 38605166