The purpose of this study is to use genomic information from individual patients to create simulation avatars that will be used to predict novel drug combinations with therapeutic potential.
As part of normal clinical care, subjects will undergo peripheral blood draws and biopsies for disease assessment of their cancer. In cases of hematological malignancies, bone marrow aspiration \& biopsy are routinely performed. As part of this project, the following will be done to the samples collected and with clinical outcomes data: * donate peripheral blood specimens whenever blood is already being drawn for clinical purposes. * donate bone marrow aspiration samples whenever a bone marrow aspiration procedure is already being done for clinical purposes. * donate saliva whenever blood draw is already being done for clinical purposes. * allow the investigators to perform gene mutation profiling. * allow the investigators to study gene mutation results. * allow the investigators to perform pharmacogenetic profiling. * allow the investigators to study pharmacogenetic profiles. * allow the investigators to examine chromosome copy number variations. * allow the investigators to examine genomic methylation. * allow the investigators to quantify metabolomics/cytokines.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
136
Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.
UF Health Shands Cancer Hospital
Gainesville, Florida, United States
Overall Response
The overall response rate (ORR) is defined as achieving a complete remission (CR), partial remission (PR), and/or hematological improvement based on 2006 International Working Group (IWG) criteria (Cheson, et al. Blood 2006).
Time frame: Up to 5 years
Number of patients with drug-related Grade 3 and Grade 4 adverse events
Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 4. Adverse event incidences will be compared to individual pharmacogenetic gene variants.
Time frame: Up to 5 years
Progression-free survival after treatment
The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.
Time frame: Up to five years
Overall survival after treatment
The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.
Time frame: Up to 5 years
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