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iCare for Cancer Patients

NCT ID: NCT02435550

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-26

Study Completion Date

2019-10-01

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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Acute Myeloid Leukemia

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

Group Type EXPERIMENTAL

Molecular diagnostic testing

Intervention Type 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.

Acute Lymphoblastic Leukemia

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

Group Type EXPERIMENTAL

Molecular diagnostic testing

Intervention Type 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.

Myelodysplastic Syndrome

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

Group Type EXPERIMENTAL

Molecular diagnostic testing

Intervention Type 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.

Myelofibrosis

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

Group Type EXPERIMENTAL

Molecular diagnostic testing

Intervention Type 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.

Multiple Myeloma

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

Group Type EXPERIMENTAL

Molecular diagnostic testing

Intervention Type 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.

Interventions

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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.

Intervention Type GENETIC

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cellworks Group Inc.

INDUSTRY

Sponsor Role collaborator

Gateway for Cancer Research

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher R. Cogle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health Shands Cancer Hospital

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OCR14209

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201500073

Identifier Type: -

Identifier Source: org_study_id