Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
NCT ID: NCT05857969
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
65 participants
INTERVENTIONAL
2023-02-22
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ex Vivo Drug Sensitivity Testing and Mutation Profiling
NCT03860376
Drug Sensitivity and Mutation Profiling
NCT04956198
Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
NCT03698994
Proof -of -Concept Study To Stratify Targeted Therapies Adapted To Molecular Profiling
NCT02613962
A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
NCT05761171
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes (response and disease-free survival) in patients with pediatric cancers treated with FPM-guided therapy as compared to non-FPM guided (conventional) therapy.
EXPLORATORY OBJECTIVE: To explore associations between tumor molecular characteristics (genomic and transcriptomic variation) and ex vivo drug response with respect to patient ethnicity.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Functional Precision Medicine
Ex Vivo Drug Sensitivity Testing + Genomic Tumor Profiling
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Functional Precision Medicine
Ex Vivo Drug Sensitivity Testing + Genomic Tumor Profiling
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Patients with newly diagnosed tumors and tumors that have high (\>90%) cure rate with safe standard therapy.
1 Day
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
OTHER
First Ascent Biomedical Inc.
INDUSTRY
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Florida International University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Diana Azzam, PhD
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Diana Azzam
Role: PRINCIPAL_INVESTIGATOR
Florida International University
Maggie Fader
Role: PRINCIPAL_INVESTIGATOR
Nicklaus Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nicklaus Children's Hospital
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
112215
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.