Overview

This trial is active, not recruiting.

Condition leukemia
Treatments microarray analysis, molecular genetic technique, mutation analysis, polymerase chain reaction, reverse transcriptase-polymerase chain reaction, diagnostic laboratory biomarker analysis
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date May 2006
End date December 2012
Trial size 735 participants
Trial identifier NCT00898092, CALGB-20502, CDR0000491133, U10CA031946, U10CA180821

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
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

Primary Outcomes

Measure
Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures
time frame: Baseline
Differential microRNA expression
time frame: Baseline
Relative contribution of genetic markers in predicting clinical outcome
time frame: Baseline

Eligibility Criteria

Male or female participants from 15 years up to 59 years old.

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

Additional Information

Official title Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.