Health Trials

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • xDRIVE Tumor Profiling

Treatment groups

210 Participants
are divided into 1 treatment group

Locations

2
First Ascent Biomedical33183, MiamiFlorida, United States
Florida International University33199, MiamiFlorida, United States

Sponsors and collaborators

First Ascent Biomedical Inc.

Lead sponsor

Florida International University

Collaborator

Source ClinicalTrials.gov