NCT05857969 Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
| NCT ID | NCT05857969 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Florida International University |
| Condition | Recurrent Childhood Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2028-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 65 participants in total. It began in 2023-02-22 with a primary completion date of 2028-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Diana Azzam
PRINCIPAL INVESTIGATOR
Florida International University
Frequently Asked Questions
Who can join the NCT05857969 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 21 Years, studying Recurrent Childhood Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05857969 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05857969 currently recruiting?
Yes, NCT05857969 is actively recruiting participants. Contact the research team at fpmlab@fiu.edu for enrollment information.
Where is the NCT05857969 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT05857969 clinical trial?
NCT05857969 is sponsored by Florida International University. The principal investigator is Diana Azzam at Florida International University. The trial plans to enroll 65 participants.
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