Adopting a Functional Precision Medicine Approach For Individualized Pediatric Cancer Treatments

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Nicklaus Children's Hospital
RECRUITING
Miami
Contact Information
Primary
Diana Azzam, PhD
fpmlab@fiu.edu
305-348-9043
Backup
Lillian Garvin
exvivotrial@nicklaushealth.org
800-533-1792
Time Frame
Start Date: 2023-02-22
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 65
Treatments
Experimental: Functional Precision Medicine for Chemorefractory or relapsed patients
We intend to enroll chemorefractory or relapsed pediatric patients with all types of cancers where tumor tissue would be available for functional precision medicine that integrates ex vivo drug screening and genomic profiling. The results of the drug sensitivity assay and genetic screening will be used to inform treating physician about patient-specific drug sensitivity or resistance guiding best therapy choices.
Sponsors
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD), First Ascent Biomedical Inc., Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Leads: Florida International University

This content was sourced from clinicaltrials.gov

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