xDRIVE personalized tumor testing for Florida cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm feasibility program enrolling 210+ Florida patients with recurrent or refractory cancers to deliver the xDRIVE Functional Precision Medicine (FPM) platform combined with artificial intelligence. Sites will obtain tumor tissue (biopsy, excision, or resection) and matched normal material (blood or buccal swab) for ex vivo drug testing and molecular profiling; results are returned to the treating physician to inform next-line therapy. The study emphasizes inclusion of pediatric patients and adults from Black, Brown, Hispanic, and rural communities and also collects health economics data to measure cost and access impacts. The primary focus is statewide feasibility and clinical utility of providing the xDRIVE platform outside major tertiary centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Ascent Biomedical
  Miami, Florida, United States Recruiting
• Florida International University
  Miami, Florida, United States Active not recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.