xDRIVE for Florida-based Cancer Patients
About this study
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).
- Condition
- Cancer, Neoplams, Refractory, Recurrence, Leukaemia, Lymphoma, Solid Tumor Malignancies, Solid Cancers
- Tested
- xDRIVE Tumor Profiling
- Sponsor
- First Ascent Biomedical Inc.
Who can join
- Age
- Not specified
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Study condition: Cancer, Neoplams, Refractory, Recurrence, Leukaemia, Lymphoma, Solid Tumor Malignancies, Solid Cancers
- 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 2
- 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.
Where
2 sites, 1 recruiting
First Ascent Biomedical
Miami, Florida, United States
Florida International University
Miami, Florida, United States
Potential match only. Final eligibility is determined by the study team.