Status:
COMPLETED
Ex Vivo Drug Sensitivity Testing and Mutation Profiling
Lead Sponsor:
Florida International University
Collaborating Sponsors:
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Conditions:
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-21 years
Brief Summary
This study is a prospective, non-randomized feasibility study. Freshly isolated tumor cells from patients will be screened using state-of-the-art viability assay designed for ex vivo high-throughput d...
Detailed Description
PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommend...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03860376
Start Date
February 21 2019
End Date
December 31 2022
Last Update
May 10 2023
Active Locations (1)
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1
Nicklaus Children's Hospital
Miami, Florida, United States, 33155