Functional precision medicine: the future of cancer care.
Arlet M Acanda de la Rocha, Noah E Berlow, Diana J Azzam
https://pubmed.ncbi.nlm.nih.gov/39567286Actively Recruiting
Led by First Ascent Biomedical Inc. · Updated on 2026-05-19
210
Participants Needed
2
Research Sites
21 weeks
Total Duration
F
First Ascent Biomedical Inc.
Lead Sponsor
F
Florida International University
Collaborating Sponsor
Researchers are evaluating the feasibility of providing the xDRIVE Functional Precision Medicine and Artificial Intelligence platform to cancer patients across Florida, especially those from underserved groups such as pediatric patients and minorities. This study aims to assess patient clinical benefit and health economic impacts by offering personalized cancer treatment support to patients with relapsed or refractory cancers. The program builds on previous promising results demonstrating actionable treatment recommendations and improved progression-free survival in pediatric patients with aggressive cancers. Participants in this single-arm feasibility study will undergo tumor profiling using the xDRIVE platform. This platform analyzes tumor samples to generate individualized treatment recommendations, which are returned to the treating physician within two weeks and may be used to guide the patient's next line of therapy. The study includes both pediatric and adult patients who have relapsed or refractory cancers and have received prior standard therapy. Blood or buccal swab samples will also be collected for matched normal DNA comparison during profiling. During the study, patients will provide tumor tissue through biopsy, excision, or resection, and treatment and outcome information from prior therapies. The research team will review progression-free survival, objective response rate, and disease control rate one year after enrollment. The study focuses on monitoring the return of treatment recommendations within a clinically actionable timeframe and gathering data on clinical benefit and health economics. Participation includes blood draws or swabs and clinical follow-up as needed, with the total study duration varying by patient.
CONDITIONS
xDRIVE for Florida-based Cancer Patients
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Return of xDRIVE data will be completed in under 2 weeks
Participants undergo tumor profiling via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis to inform their next line of cancer treatment.
1 visit for tumor biopsy or sample collection
Duration - 1 year after enrollment
Participants are monitored for treatment outcomes such as progression-free survival and response rates over the course of 1 year after enrollment.
Periodic follow-up visits as determined by the treating physician
Total: 2 locations
1
First Ascent Biomedical
Miami, Florida, United States, 33183
Actively Recruiting
2
Florida International University
Miami, Florida, United States, 33199
Active, Not Recruiting
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Arlet M Acanda de la Rocha, Noah E Berlow, Diana J Azzam
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https://pubmed.ncbi.nlm.nih.gov/38605166