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NCT05857969 · ClinicalTrials.gov registry record · Phase 1
Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
A Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia and Recurrent Childhood Rhabdomyosarcoma, sponsored by Florida International University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT05857969: Recruiting Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia and Recurrent Childhood Rhabdomyosarcoma, sponsored by Florida International University.
NCT05857969 is a Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia and Recurrent Childhood Rhabdomyosarcoma that is actively recruiting participants, run by Florida International University. The registered enrollment target is 65 participants, below the 121-participant average among 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05857969, a Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia and Recurrent Childhood Rhabdomyosarcoma, is actively recruiting participants, sponsored by Florida International University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This study will be considered successful (feasibility demonstrated) if it is possible to choose and initiate a monotherapy or combination drug regimen based on functional and/or genomics data within 4 weeks in at least 39 out of 65 patients (60%). To achieve at least 90% power, the null hypothesis will be rejected when at least 39 out of 65 patients receive treatment recommendations through functional and/or genomics data within 4 weeks on the study. With that outcome, we would have 95% confid
Conditions Studied
Interventions
- DEVICE Functional Precision Medicine
Study Locations (1)
Florida
- Nicklaus Children's Hospital - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-02-22 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
What NCT05857969 shows while recruiting
NCT05857969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 121-participant average among 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials with a reported enrollment target (46% lower).
The record links to 10 conditions, with Recurrent Childhood Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Functional Precision Medicine is the first listed.
NCT05857969 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05857969 about?
NCT05857969 is a clinical study titled "Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling". 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 ca...
What is the current status of trial NCT05857969?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2023-02-22. Estimated completion is 2028-12-31.
What conditions does trial NCT05857969 study?
This clinical trial studies the following conditions: Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Brain Stem Glioma.
What interventions are being tested in trial NCT05857969?
The interventions under investigation include: Functional Precision Medicine (DEVICE).
Who is sponsoring clinical trial NCT05857969?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05857969 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Childhood Acute Lymphoblastic Leukemia
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Where NCT05857969's enrollment target sits among peer trials
65 7th of 11 higher than 5 of 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Childhood Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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