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iCare for Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435550
Recruitment Status : Terminated (Halted due to funding issues.)
First Posted : May 6, 2015
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Cellworks Group Inc.
Gateway for Cancer Research
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE April 20, 2015
First Posted Date  ICMJE May 6, 2015
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE June 26, 2015
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iCare for Cancer Patients
Official Title  ICMJE iCare for Cancer Patients
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia
  • Acute Myelogenous Leukemia
  • Acute Lymphoid Leukemia
  • Leukemia, Acute Lymphoblastic
  • Multiple Myeloma
  • Myelofibrosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Genetic: Molecular diagnostic testing
  • 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.
    Intervention: Genetic: Molecular diagnostic testing
  • Experimental: Myelodysplastic Syndrome
    Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
    Intervention: Genetic: Molecular diagnostic testing
  • Experimental: Myelofibrosis
    Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
    Intervention: Genetic: Molecular diagnostic testing
  • Experimental: Multiple Myeloma
    Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
    Intervention: Genetic: Molecular diagnostic testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 1, 2019)
136
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2015)
180
Actual Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02435550
Other Study ID Numbers  ICMJE IRB201500073
OCR14209 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • Cellworks Group Inc.
  • Gateway for Cancer Research
Investigators  ICMJE
Principal Investigator: Christopher R. Cogle, MD University of Florida
PRS Account University of Florida
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP