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Search / Trial NCT05857969

Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Launched by FLORIDA INTERNATIONAL UNIVERSITY · May 5, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ex Vivo Drug Sensitivity Assay Genomic Profiling Functional Precision Medicine Biomarker Development

ClinConnect Summary

This clinical trial is studying a new way to treat certain types of childhood cancers, including leukemia and brain tumors, by using a method called functional precision medicine. This approach involves taking tumor cells from patients and testing them directly with different cancer drugs to see which ones work best for that individual. The goal is to find the most effective treatment for each child based on their unique cancer profile. The study is currently looking for young patients aged 21 years or younger who have cancers that have come back or are hard to treat and who have had a biopsy or surgery recently.

Eligible participants will have their tumor cells tested in the lab, along with genetic testing to better understand their cancer. Parents or guardians will need to give permission for their children to join the study, and children aged 7 to 17 will be asked to agree to participate as well. It's important to know that participants need to have enough tumor tissue available for testing, and the study is not for those with newly diagnosed tumors that have high chances of being cured with standard treatments. This trial aims to help find more personalized and effective treatment options for children facing these challenging cancers.

Gender

ALL

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.

About Florida International University

Florida International University (FIU) is a leading public research institution dedicated to advancing knowledge and improving health outcomes through innovative clinical trials. With a commitment to excellence in research and a diverse faculty of experts, FIU supports multidisciplinary studies that address critical health challenges. The university leverages its state-of-the-art facilities and a collaborative approach to foster groundbreaking research, ensuring that findings contribute meaningfully to the scientific community and public health. Through its clinical trials, FIU aims to enhance patient care and promote health equity in the communities it serves.

Locations

Miami, Florida, United States

Patients applied

0 patients applied

Trial Officials

Diana Azzam

Principal Investigator

Florida International University

Maggie Fader

Principal Investigator

Nicklaus Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported