xDRIVE for Florida-based Cancer Patients (NCT07167381) | Clinical Trial Compass
RecruitingNot Applicable
xDRIVE for Florida-based Cancer Patients
United States210 participantsStarted 2025-11-01
Plain-language summary
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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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