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iCare for Cancer Patients

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ClinicalTrials.gov Identifier: NCT02435550
Recruitment Status : Suspended (insufficient staff)
First Posted : May 6, 2015
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
Cellworks Group Inc.
Gateway for Cancer Research
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Acute Myeloid Leukemia Acute Myelogenous Leukemia Acute Lymphoid Leukemia Leukemia, Acute Lymphoblastic Multiple Myeloma Myelofibrosis Genetic: Molecular diagnostic testing Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 435 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: iCare for Cancer Patients
Actual Study Start Date : June 26, 2015
Estimated Primary Completion Date : June 26, 2020
Estimated Study Completion Date : June 26, 2021


Arm Intervention/treatment
Experimental: Acute Myeloid Leukemia
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
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.

Experimental: Acute Lymphoblastic Leukemia
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
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.

Experimental: Myelodysplastic Syndrome
Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Genetic: Molecular diagnostic testing
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.

Experimental: Myelofibrosis
Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Genetic: Molecular diagnostic testing
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.

Experimental: Multiple Myeloma
Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Genetic: Molecular diagnostic testing
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 Outcome Measures :
  1. Overall Response [ Time Frame: 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 Outcome Measures :
  1. Number of patients with drug-related Grade 3 and Grade 4 adverse events [ Time Frame: 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.

  2. Progression-free survival after treatment [ Time Frame: Up to five years ]
    The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.

  3. Overall survival after treatment [ Time Frame: Up to 5 years ]
    The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435550


Locations
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United States, Florida
UF Health Shands Cancer Hospital
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Cellworks Group Inc.
Gateway for Cancer Research
Investigators
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Principal Investigator: Christopher R. Cogle, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02435550     History of Changes
Other Study ID Numbers: IRB201500073
OCR14209 ( Other Identifier: OnCore )
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Preleukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Primary Myelofibrosis
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Myeloproliferative Disorders
Lymphatic Diseases