Actively Recruiting

Phase 1
Age: 1Day - 21Years
All Genders
NCT05857969

Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Led by Florida International University · Updated on 2025-07-11

65

Participants Needed

1

Research Sites

305 weeks

Total Duration

On this page

Sponsors

F

Florida International University

Lead Sponsor

N

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Who Can Participate

Age: 1Day - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 21 years or younger at enrollment of any gender, race, or ethnicity
  • Suspected or confirmed diagnosis of recurrent or refractory cancer
  • Scheduled for or recently had biopsy, tumor excision (solid tumors), or bone marrow aspirate (blood cancers)
  • Willing to have blood drawn or buccal swab for genetic testing
  • Patients or their parents/legal guardians willing to sign informed consent
  • Patients aged 7 to 17 years willing to sign assent
Not Eligible

You will not qualify if you...

  • No accessible malignant tissue available
  • Insufficient amount of excised malignant tissue for drug testing or genetic profiling
  • Newly diagnosed tumors
  • Tumors with greater than 90% cure rate using safe standard therapy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

Actively Recruiting

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Research Team

D

Diana Azzam, PhD

CONTACT

L

Lillian Garvin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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