RECRUITING

Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

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Conditions

Recurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Large Cell LymphomaRefractory Childhood Acute Lymphoblastic LeukemiaRefractory Childhood Hodgkin LymphomaRefractory Childhood Malignant Germ Cell NeoplasmRecurrent Childhood Brain TumorRecurrent Childhood Brainstem GliomaRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Soft Tissue SarcomaRecurrent Childhood EpendymomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood GliosarcomaRefractory Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRefractory Childhood Malignant Solid NeoplasmRecurrent Childhood Malignant Solid NeoplasmRecurrent Childhood Malignant NeoplasmRefractory Childhood Malignant Neoplasmex vivo drug sensitivity assaygenomic profilingFunctional precision medicineBiomarker development

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adopting a Functional Precision Medicine Approach to Reduce Cancer Disparities in Hispanic and Black Children of Miami

Quick Facts

Study Start:2023-02-22
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05857969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity.
  1. * 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.

Contacts and Locations

Study Contact

Diana Azzam, PhD
CONTACT
305-348-9043
fpmlab@fiu.edu
Lillian Garvin
CONTACT
800-533-1792
exvivotrial@nicklaushealth.org

Principal Investigator

Diana Azzam
PRINCIPAL_INVESTIGATOR
Florida International University
Maggie Fader
PRINCIPAL_INVESTIGATOR
Nicklaus Children's Hospital

Study Locations (Sites)

Nicklaus Children's Hospital
Miami, Florida, 33155
United States

Collaborators and Investigators

Sponsor: Florida International University

  • Diana Azzam, PRINCIPAL_INVESTIGATOR, Florida International University
  • Maggie Fader, PRINCIPAL_INVESTIGATOR, Nicklaus Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-22
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-02-22
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • ex vivo drug sensitivity assay
  • genomic profiling
  • Functional precision medicine
  • Biomarker development

Additional Relevant MeSH Terms

  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Large Cell Lymphoma
  • Refractory Childhood Acute Lymphoblastic Leukemia
  • Refractory Childhood Hodgkin Lymphoma
  • Refractory Childhood Malignant Germ Cell Neoplasm
  • Recurrent Childhood Brain Tumor
  • Recurrent Childhood Brainstem Glioma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Gliosarcoma
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Refractory Childhood Malignant Solid Neoplasm
  • Recurrent Childhood Malignant Solid Neoplasm
  • Recurrent Childhood Malignant Neoplasm
  • Refractory Childhood Malignant Neoplasm