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Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
NCT05857969 · Florida International University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Adopting a Functional Precision Medicine Approach For Individualized Pediatric Cancer Treatments
About this study
PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on Functional Precision Medicine (FPM), the combination of ex vivo drug sensitivity testing (DST) and genomic profiling.
SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes (response and disease-free survival) in patients with pediatric cancers treated with FPM-guided therapy as compared to non-FPM guided (conventional) therapy.
EXPLORATORY OBJECTIVE: To explore associations between tumor molecular characteristics (genomic and transcriptomic variation) and ex vivo drug response with respect to patient ethnicity.
Eligibility criteria
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.
Study design
Enrollment target: 65 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2023-02-22
Estimated completion: 2028-12-31
Last updated: 2025-07-11
Interventions
Device: Functional Precision Medicine
Primary outcomes
- • Percentage of Patients that receive Functional Precision Medicine (FPM)-guided treatment options (Up to 6 years)
Sponsor
Florida International University · other
With: Nicklaus Children's Hospital f/k/a Miami Children's Hospital, First Ascent Biomedical Inc., National Institute on Minority Health and Health Disparities (NIMHD)
Contacts & investigators
ContactDiana Azzam, PhD · contact · fpmlab@fiu.edu · 305-348-9043
ContactLillian Garvin · contact · exvivotrial@nicklaushealth.org · 800-533-1792
InvestigatorDiana Azzam · principal_investigator, Florida International University
InvestigatorMaggie Fader · principal_investigator, Nicklaus Children's Hospital
All locations (1)
Nicklaus Children's HospitalRecruiting
Miami, Florida, United States