NCT05857969RecruitingPhase 1
Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
Advancing Personalized Treatment in Pediatric Oncology Through Functional Precision Medicine
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 5 May 2023
- Start date
- 22 Feb 2023
- Primary completion date
- 22 Feb 2028
- Lead sponsor
- Florida International University
- Diseases
- Acute lymphoblastic leukaemia, Chronic myeloid leukaemia, Chronic lymphocytic leukaemia, Acute myeloid leukemia, Childhood cancers, Sarcoma
- NCT number
- NCT05857969
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 65
- From 22 Feb 2023 to the primary completion date, 22 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 1 day to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nicklaus Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.