xDRIVE for Florida-based Cancer Patients

This study is testing a new approach called xDRIVE Tumor Profiling for cancer patients in Florida. This approach uses advanced lab tests and artificial intelligence to analyze your tumor and provide information to your doctor. The goal is to see if this information can help doctors make treatment decisions within two weeks. You might be able to join if you are a child or adult with cancer that has come back or not responded to previous treatments, and you have already received at least one standard treatment. This study is particularly focused on helping underserved communities, including children and those in Black, Brown, Hispanic, and rural areas. The study aims to enroll at least 210 patients.

Study design
This is a single-arm study, meaning all participants will receive the xDRIVE Tumor Profiling. It plans to enroll at least 210 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint focuses on the return of treatment recommendations within two weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07167381

xDRIVE for Florida-based Cancer Patients

Recruiting
NAAll AgesInterventionalTreatment
First Ascent Biomedical Inc.
~210 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:xDRIVE Tumor Profiling

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Return of treatment recommendations from xDRIVE functional precision medicine platform within a clinically-actionable timeframe
Measured over Return of xDRIVE data will be completed in under 2 weeks
Cancer
Neoplams
Refractory
Recurrence
Leukaemia
Lymphoma
Solid Tumor Malignancies
Solid Cancers
2 sites across 1 states
Florida2

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Eligibility criteria

Inclusion

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

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.
  • Return of treatment recommendations from xDRIVE functional precision medicine platform within a clinically-actionable timeframeReturn of xDRIVE data will be completed in under 2 weeks

    Tumor tissues provided by patients will undergo drug sensitivity testing and molecular tumor profiling in order to identify individualized treatment options. Treatment recommendations from both tumor profiling methods will be returned to the patient and physician to support clinical decision-making. Return of data in a timeframe fast enough to support decision-making is critical for showing clinical feasibility of this approach around the state of Florida. Feasibility will be demonstrated if xDRIVE treatment recommendations are returned within 2 weeks for at least 151 of 210 patients (72%), which is sufficient to reject the null hypothesis (≤60% of patients receiving treatment recommendations) with \>95% power (α = 0.025).