Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia
NCT ID: NCT00898092
Last Updated: 2021-08-17
Study Results
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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UNKNOWN
735 participants
OBSERVATIONAL
2006-05-31
Brief Summary
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PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.
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Detailed Description
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* Validate, on the larger number of patients with karyotypically normal acute myeloid leukemia (AML) treated uniformly on CALGB-19808, preliminary results from CALGB-9621 showing that BAALC and ERG overexpression and microarray gene-expression signatures can stratify the patients prognostically.
* Establish whether microRNAs are differentially expressed in subsets of patients with AML and normal cytogenetics, and, if so, attempt to identify a signature that stratifies patients prognostically.
* Explore the relative contribution in predicting clinical outcome of patients with cytogenetically normal AML using genetic markers such as BAALC, ERG, and EVI1 overexpression, MLL partial tandem duplication, FLT3 internal tandem duplication, NPM1 and CEBPA mutations, and microarray gene expression microRNA signatures.
OUTLINE: This is a multicenter, pilot study.
Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Group 1
Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.
microarray analysis
molecular genetic technique
mutation analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
diagnostic laboratory biomarker analysis
Interventions
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microarray analysis
molecular genetic technique
mutation analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
diagnostic laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute myeloid leukemia
* Normal karyotype
* Bone marrow and/or peripheral blood samples from patients treated on CALGB-19808 and registered on CALGB-9665 required
* No additional samples required
15 Years
59 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Guido Marcucci, MD
Role: STUDY_CHAIR
Ohio State University Comprehensive Cancer Center
Locations
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Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Other Identifiers
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CALGB-20502
Identifier Type: -
Identifier Source: secondary_id
CDR0000491133
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-20502
Identifier Type: -
Identifier Source: org_study_id
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