iCare for Cancer Patients

University of Florida

Status: Terminated

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

Treatments: Genetic: Molecular diagnostic testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02435550

OCR14209 (Other Identifier)

IRB201500073

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 5 patient groups

Acute Myeloid Leukemia

Experimental group

Description:

Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Treatment:

Genetic: Molecular diagnostic testing

Acute Lymphoblastic Leukemia

Experimental group

Description:

Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care.

Treatment:

Genetic: Molecular diagnostic testing

Myelodysplastic Syndrome

Experimental group

Description:

Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Treatment:

Genetic: Molecular diagnostic testing

Myelofibrosis

Experimental group

Description:

Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Treatment:

Genetic: Molecular diagnostic testing

Multiple Myeloma

Experimental group

Description:

Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Treatment:

Genetic: Molecular diagnostic testing