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Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

RECRUITINGPhase 1Sponsored by Florida International University
Actively Recruiting
PhasePhase 1
SponsorFlorida International University
Started2023-02-22
Est. completion2028-02-22
Eligibility
Age1 Day – 21 Years
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 1 Day – 21 YearsHealthy volunteers accepted
Inclusion Criteria:

* Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity.

Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing Subjects or their parents or legal guardians willing to sign informed consent Subjects aged 7 to 17 willing to sign assent

Exclusion Criteria:

* Subjects who do not have malignant tissue available and accessible The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.

Patients with newly diagnosed tumors and tumors that have high (\>90%) cure rate with safe standard therapy.

Conditions19

CancerRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Brain TumorRecurrent Childhood Brainstem GliomaRecurrent Childhood EpendymomaRecurrent Childhood GliosarcomaRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Malignant Neoplasm

Locations1 site

Nicklaus Children's Hospital
Miami, Florida, 33155
Darika Sartmatova800-533-1792exvivotrial@nicklaushealth.org

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