Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Functional precision medicine (FPM) is a relatively new approach to cancer therapy based on direct exposure of patient- isolated tumor cells to clinically approved drugs and integrates ex vivo drug sensitivity testing (DST) and genomic profiling to determine the optimal individualized therapy for cancer patients. In this study, we will enroll relapsed or refractory pediatric cancer patients with tissue available for DST and genomic profiling from the South Florida area, which is 69% Hispanic and 18% Black. Tumor cells collected from tissue taken during routine biopsy or surgery will be tested.

NCT Number	NCT05857969
Lead Sponsor	Florida International University Collaborators: Nicklaus Children's Hospital f/k/a Miami Children's Hospital, First Ascent Biomedical Inc., National Institute on Minority Health and Health Disparities (NIMHD)
Conditions	Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Large Cell Lymphoma, Refractory Childhood Acute Lymphoblastic Leukemia, Refractory Childhood Hodgkin Lymphoma, Refractory Childhood Malignant Germ Cell Neoplasm, Recurrent Childhood Brain Tumor, Recurrent Childhood Brainstem Glioma +10 more
Enrollment	65 participants
Start Date	2023-02-22
Primary Completion	2028-02-22 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-11