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
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   15 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898092

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Guido Marcucci, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00898092     History of Changes
Other Study ID Numbers: CDR0000491133, CALGB-20502
Study First Received: May 9, 2009
Last Updated: July 12, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute eosinophilic leukemia
adult acute basophilic leukemia
untreated adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 14, 2014