Clinical trial · Interventional
Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
Advancing Personalized Treatment in Pediatric Oncology Through Functional Precision Medicine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Childhood Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Recurrent Childhood Brainstem Glioma | Childhood Brain Stem Glioma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Brain Tumor | Childhood Brain Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Childhood Ependymoma | Childhood Ependymoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Gliosarcoma | Childhood Gliosarcoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Childhood Lymphoblastic Lymphoma | Childhood Lymphoblastic Lymphoma | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Functional Precision Medicine | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Functional Precision Medicine for Chemorefractory or relapsed patients
- description
- 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.
- interventionNames
- Device: Functional Precision Medicine
Primary outcomes (1)
- measure
- Percentage of Patients that receive Functional Precision Medicine (FPM)-guided treatment options
- timeFrame
- Up to 6 years
- description
- 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% confidence that the true feasibility rate is at least 40% (95% CI: 0.4905 to 1).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available