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| ID | Type | Description | Link |
|---|---|---|---|
| OCR14209 | Other Identifier | OnCore |
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Halted due to funding issues.
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| Name | Class |
|---|---|
| Cellworks Group Inc. | INDUSTRY |
| Gateway for Cancer Research | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Myeloid Leukemia | Experimental | Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. |
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| Acute Lymphoblastic Leukemia | Experimental | Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care. |
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| Myelodysplastic Syndrome | Experimental | Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. |
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| Myelofibrosis | Experimental | Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. |
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| Multiple Myeloma | Experimental | Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher R. Cogle, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health Shands Cancer Hospital | Gainesville | Florida | 32608 | United States |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009101 | Multiple Myeloma |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| D025202 | Molecular Diagnostic Techniques |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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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 |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D009196 | Myeloproliferative Disorders |
| D005821 | Genetic Techniques |