Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898092
First received: May 9, 2009
Last updated: July 12, 2012
Last verified: January 2012

May 9, 2009
July 12, 2012
May 2006
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  • Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures [ Designated as safety issue: No ]
  • Differential microRNA expression [ Designated as safety issue: No ]
  • Relative contribution of genetic markers in predicting clinical outcome [ Designated as safety issue: No ]
  • Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures
  • Differential microRNA expression
  • Relative contribution of genetic markers in predicting clinical outcome
Complete list of historical versions of study NCT00898092 on ClinicalTrials.gov Archive Site
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Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia
Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project

RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.

OBJECTIVES:

  • 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.

Observational
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Leukemia
  • Genetic: microarray analysis
  • Genetic: molecular genetic technique
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: diagnostic laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
15 Years to 59 Years
No
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United States
 
NCT00898092
CDR0000491133, CALGB-20502
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Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Guido Marcucci, MD Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
January 2012

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