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xDRIVE for Florida-based Cancer Patients

xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed/ Refractory Cancers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the xDRIVE platform, which uses artificial intelligence (AI), can help guide cancer care across Florida and how it affects health care costs. It is for children and adults whose cancer has come back or has not responded to treatment, with a focus on underserved communities. Doctors will get the results and may use them to help choose the next treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have cancer that has come back or has not responded to treatment. Children and adults may join.
  • Children ages 7–17 must be willing to sign a form agreeing to take part.
  • Have had at least one standard cancer treatment.
  • Can provide details about past treatments and their results.
  • Are healthy enough for cancer treatment. Adults should have an ECOG activity score of 0–2, meaning they can care for themselves and are up and about at least half the day.
  • Are scheduled for, or recently had, a procedure to take a tumor sample or remove a tumor.
  • Are willing to give a blood sample or an inside-cheek swab to compare normal DNA with tumor DNA.

Who can't join

  • Do not have enough available cancer tissue or cancer cells for drug testing outside the body or gene testing. This includes removed tissue weighing less than 0.3 grams, needle samples with no cancer found, or blood or bone marrow samples with too few cancer cells.
  • Are not healthy enough to receive cancer treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

FL