Beat AML Core Study
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|ClinicalTrials.gov Identifier: NCT02927106|
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : July 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Genetic: Genomics Diagnostic Test: Drug Sensitivity Assay Genetic: Proteomics||Not Applicable|
As part of normal clinical care, patients will undergo a peripheral blood draw and bone marrow aspiration & biopsy. Blood draws and bone marrow aspirations are performed at the time of diagnosis, after treatments , disease progression, and relapse. Under normal clinical care, patient specimens are analyzed by cytogenetics (giemsa staining), fluorescence in situ hybridization (FISH), and gene mutation profiling. Clinically, treatment can begin before these molecular diagnostics are available.
As part of this repository study, subjects are asked to:
- Allow access to banked blood and bone marrow specimens in IRB approved protocol # 532-2012.
- Donate peripheral blood specimens whenever blood is already being drawn for clinical purposes such as at times of diagnosis, relapse, refractory disease or disease progression. Additional samples may be requested at other standard of care visits in the event that initial samples are not viable for DNA sequencing, phenotyping, or functional assays for patients with AML, if disease is present.
- Donate bone marrow aspirate specimens whenever bone marrow aspiration is already being done for clinical purposes such as at times of diagnosis, relapse, refractory disease or disease progression. If bone marrow aspirate is being collected for banking protocol #532-2012, then an aliquot of the banked specimen will be accessed rather than collect an additional bone marrow aspirate for this study.
- Undergo skin biopsy and donate the skin biopsy specimen for genomic profiling.
- Allow bone marrow, peripheral blood and skin biopsy specimens to be collected for genomic profiling and ex vivo drug sensitivity testing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beat AML: Personalized Medicine for Acute Myeloid Leukemia Based on Functional Genomics|
|Actual Study Start Date :||February 15, 2017|
|Estimated Primary Completion Date :||February 15, 2024|
|Estimated Study Completion Date :||February 15, 2025|
Experimental: Acute Myeloid Leukemia (AML)
AML samples will be collected from individuals with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) as defined by World Health Organization 2016.
AML cells will be examined by Next Generation Sequencing using an Illumina DNA sequencer.
Other Name: Computational Biology
Diagnostic Test: Drug Sensitivity Assay
Ex vivo drug sensitivity testing will be performed on AML cells.
Biomarkers and genomic signatures will be identified in AML cells that correlate with disease response and adverse events.
- the genomic abnormality spectrum [ Time Frame: 5 years ]AML cells in the peripheral blood and bone marrow samples will be examined by next generation sequencing using an Illumina DNA sequencer. DNA from the skin biopsy will be used as the constitutional reference DNA. Using skin DNA greatly improves the ability to accurately and precisely identify somatic mutations in the AML cells.
- drug sensitivity [ Time Frame: 5 years ]Ex vivo drug sensitivity testing will be performed on each subject's AML cells derived from peripheral blood and bone marrow. AML cell viability will be recorded for each treatment condition after 72 hours of treatment. A rank-ordered list of drugs will be created in order of drug toxicity.
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): NCT02927106
|Contact: Barry C. Sawicki||(352) firstname.lastname@example.org|
|Contact: Caitlin D. Tucker, RN||(352) email@example.com|
|United States, Florida|
|UF Health Cancer Center||Recruiting|
|Gainesville, Florida, United States, 32608|
|Contact: Barry Sawicki 352-273-9148 firstname.lastname@example.org|
|Principal Investigator:||Christopher R. Cogle, MD||University of Florida|