Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898092
First received: May 9, 2009
Last updated: July 23, 2015
Last verified: July 2015

May 9, 2009
July 23, 2015
May 2006
December 2012   (final data collection date for primary outcome measure)
  • Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Differential microRNA expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Relative contribution of genetic markers in predicting clinical outcome [ Time Frame: Baseline ] [ 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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients enrolled on CALGB 19808 with tissue previously submitted to the CALGB Leukemia Tissue Bank

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
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
735
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Both
15 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00898092
CALGB-20502, CALGB-20502, U10CA031946, U10CA180821, CDR0000491133
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Guido Marcucci, MD Ohio State University Comprehensive Cancer Center
Alliance for Clinical Trials in Oncology
July 2015

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