iCare for Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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iCare for Cancer Patients

Conditions
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Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Leukemia, Acute Lymphoblastic, Multiple Myeloma, Myelofibrosis

Intervention / Treatment
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* Genetic: Molecular diagnostic testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute Myeloid Leukemia<br>Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. | Genetic: Molecular diagnostic testing<br>* 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.<br>|
| Experimental: Acute Lymphoblastic Leukemia<br>Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care. | Genetic: Molecular diagnostic testing<br>* 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.<br>|
| Experimental: Myelodysplastic Syndrome<br>Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. | Genetic: Molecular diagnostic testing<br>* 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.<br>|
| Experimental: Myelofibrosis<br>Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. | Genetic: Molecular diagnostic testing<br>* 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.<br>|
| Experimental: Multiple Myeloma<br>Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. | Genetic: Molecular diagnostic testing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to 5 years |