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Taking people in United StatesPhase 1

Tests tumor cells from children with relapsed or refractory cancers against drugs

Tests tumor cells from children with hard-to-treat leukemia or lymphoma.

Plain-language title generated from the registry record
Registry title: Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Key facts

Where
Miami, United StatesSee the site
Phase
Phase 1

Where in United States

  • Nicklaus Children's HospitalMiami, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Florida International University
Trial code
NCT05857969
Record updated
26 August 2026
Original description
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.Read full original descriptionShow less

Advancing Personalized Treatment in Pediatric Oncology Through Functional Precision Medicine

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT05857969