Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00898092
Collaborator
National Cancer Institute (NCI) (NIH)
735
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
735 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project
Actual Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures [Baseline]

  2. Differential microRNA expression [Baseline]

  3. Relative contribution of genetic markers in predicting clinical outcome [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210-1240

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Guido Marcucci, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898092
Other Study ID Numbers:
  • CALGB-20502
  • CALGB-20502
  • U10CA031946
  • U10CA180821
  • CDR0000491133
First Posted:
May 12, 2009
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021

Study Results

No Results Posted as of Aug 17, 2021