iCare for Cancer Patients

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.

• Molecular diagnostic testing (Genetic): 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.

Primary outcomes

• Overall Response [Up to 5 years]: 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).

Secondary outcomes

• Number of patients with drug-related Grade 3 and Grade 4 adverse events [Up to 5 years]: 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.
• Progression-free survival after treatment [Up to five years]: The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.
• Overall survival after treatment [Up to 5 years]: The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Individuals known or suspected of having a blood cancer or hematologic disorder
* Individuals with presence of extramedullary disease
* Capable of providing informed consent.

Exclusion Criteria:

* Does not have a blood cancer or a hematologic disorder

• Christopher R. Cogle, MD, Principal investigator, University of Florida